DECISIONS OF 85TH MEETING OF MEDICAL DEVICE BOARD

HELD ON 21-03-2025

REGISTRATION OF MEDICAL DEVICES FOR IMPORT.

S.No. Name of Manufacturers Detaiol Name of Medical Device Decision

Importer
1. Radiant Legal Manufacturer: P290 A1/ P290 A2/ P290 A3 Approved subject to
Medical (Pvt) Hill-Rom S.A.S. Z.I. du Talhouet Alternating Pressure Bed Mattress submission of Brand
Ltd, 06 Sher 56330 Pluvigner - France. System name.
Shah Block, FSC: France.
New Garden Class-A
Town, Lahore. Issuance 10-02-2021
LOA validity 30-09-2026 Shelf Life: N/A
ELI-00135
Date of R& I Models:
01‐Feb‐2024 P290 A1/ P290 A2/ P290 A3
Fee
Rs. 25,000/
2. M/s Mezan Legal Manufacture: Acto Oxy Wipes Content of 100g Approved
International (ACTO GMBH Schulstrasse Soaking Solution: 3,0% Hydrogen
59BRII Opp 8,31613 Wietzen Braunschweig peroxide and auxiliary substances
DCO House Germany Tel:+49531 239 50 80
Haji Meherban Tel:+495022 98 01 46 Class B
Road,Bilal Email:[email protected]
Town Jhelum website:www.actogmbh.com Shelf life: 2 Years
ELI-00096 Manufacturing Site (s): (Acto
R&I Details 17- Pharma Higyen San.Tic A.S Codes/
02-2025 Akcaburgaz Mahallesi.3038 Sok Pack Sizes: Pack of 100 wipes
Fee Challan No No.1134522 Esenyurt
6969682056 Istanbul,Turkey Tel:+90 212 771
Dated 15-2- 5622 Email: [email protected]
website: www.actopharma.com )

LOA: Validity 24-11-2027 FSC:

Country of Origin Validity: 20-10-
2025 Acto gmbh FSC: FSC of
Reference Country (as mentioned in
rule, 67) Validity: Acto Pharma:20-
10-2025 Acto gmbh : OR
2025 EC Certificate: Validity: FQA
Acto phrama 27-05-2024 Acto
gmbh 27-05-2024 Extension MDR
Letter OR WHO PQ (verifiable
from the official WHO site) ISO
13485: Validity: Acto Pharma 20-
12-2025 Acto gmbh 10-03-2025
3. M/s Mezan Legal Manufacture: Acto Oxy Foam Approved
International (ACTO GMBH Schulstrasse Content of 100g Solution: 2.6%
59BRII Opp 8,31613 Wietzen Braunschweig Hydrogen peroxide, ethanol and
DCO House Germany Tel:+49531 239 50 80 auxiliary substances
Haji Meherban Tel:+495022 98 01 46
Road,Bilal Email:[email protected] Class B
Town Jhelum website:www.actogmbh.com
ELI-00096 Manufacturing Site (s): (Acto Shelf life: 3 Years

Decisions of 85th Meeting of MDB (21-03-2025) Page 1 of 138

 R&I Details Pharma Higyen San.Tic A.S
17-02-2025 Akcaburgaz Mahallesi.3038 Sok Codes/Sizes
Fee Challan No No.1134522 Esenyurt Pack Sizes:
91041641 Istanbul,Turkey Tel:+90 212 771 500ml,750ml,4500ml,1Liter,5 Liter
Dated 15-2- 5622 Email: [email protected]
2025 website: www.actopharma.com )

LOA: Validity 24-11-2027 FSC:

Country of Origin Validity: 20-10-
2025 Acto gmbh FSC: FSC of
Reference Country (as mentioned in
rule, 67) Validity: Acto Pharma:20-
10-2025 Acto gmbh : OR
2025 EC Certificate: Validity: FQA
Acto phrama 27-05-2024 Acto
gmbh 27-05-2024 Extension MDR
Letter OR WHO PQ (verifiable
from the official WHO site) ISO
13485: Validity: Acto Pharma 20-
12-2025 Acto gmbh 10-03-2025
4. Gulfam Legal Manufacturer: Undis Approved
Brothers SHAOXING UNDIS MEDICAL Disposable Heat and Moisture
House No.1-C, TECHNOLOGY CO., LTD Exchange
Green Villa, Address: No.12 Yuexing
Zaildar Park, Technology Park, No.11 Fanrong Sizes: Codes:
Ichra, Lahore, Road, Binhai New Area, 312366
Pakistan Shaoxing, Zhejiang Province, HME-01, HME-02 HME-03,
PEOPLE’S REPUBLIC OF CHINA HME-04
ELI No.: ELI-
00028 FSC Valid till: 17-06-2026 Class-B

EC Valid till: 31-12-2028 Shelf life: 5 Years

ISO Valid till: 19-06-2025 DRAP Application Receiving

Date:
24-12-2024

DRAP Fees:
Rs: 31,000/-
Challan No.
4961394392
Dated 20-12-2024

5. Gulfam Legal Manufacturer: Undis Approved

Brothers SHAOXING UNDIS MEDICAL Disposable Nasal Oxygen Cannula
House No.1-C, TECHNOLOGY CO., LTD
Green Villa, Address: No.12 Yuexing
Zaildar Park, Technology Park, No.11 Fanrong Sizes: Codes:
Ichra, Lahore, Road, Binhai New Area, 312366
Pakistan Shaoxing, Zhejiang Province, N01,N02,N03,D01,
PEOPLE’S REPUBLIC OF CHINA D02,S01,W01,W02
ELI No.: ELI-
00028 FSC Valid till: 17-06-2026 Class-B

EC Valid till: 31-12-2028 Shelf life: 5 Years

ISO Valid till: 19-06-2025 DRAP Application Receiving

Date:
24-12-2024

Decisions of 85th Meeting of MDB (21-03-2025) Page 2 of 138

 DRAP Fees:
Rs: 31,000/-
Challan No.
083974337
Dated 20-12-2024

6. Gulfam Legal Manufacturer: Undis Approved

Brothers SHAOXING UNDIS MEDICAL Disposable Nebulizer Mask
House No.1-C, TECHNOLOGY CO., LTD
Green Villa, Address: No.12 Yuexing
Zaildar Park, Technology Park, No.11 Fanrong Sizes: Codes:
Ichra, Lahore, Road, Binhai New Area, 312366
Pakistan Shaoxing, Zhejiang Province, WHQ-01-01
PEOPLE’S REPUBLIC OF CHINA WHQ-01-02
ELI No.: ELI- WHQ-01-03
00028 FSC Valid till: 17-06-2026 WHQ-01-04
EC Valid till: 31-12-2028 Class-B

ISO Valid till: 19-06-2025 Shelf life: 5 Years

DRAP Application Receiving

Date:
24-12-2024

DRAP Fees:
Rs: 31,000/-
Challan No.
06671944553
Dated 20-12-2024

7. Gulfam Legal Manufacturer: Undis Approved subject to

Brothers SHAOXING UNDIS MEDICAL Disposable Closed Suction System submission of fee as
House No.1-C, TECHNOLOGY CO., LTD per revised SRO for
Green Villa, Address: No.12 Yuexing the System.
Zaildar Park, Technology Park, No.11 Fanrong Sizes: Codes:
Ichra, Lahore, Road, Binhai New Area, 312366 CSS-A05PY
Pakistan Shaoxing, Zhejiang Province, CSS-A06PY
PEOPLE’S REPUBLIC OF CHINA CSS-A07PY
ELI No.: ELI- CSS-A08PY
00028 FSC Valid till: 17-06-2026 CSS-A10EY
CSS-A12EY
EC Valid till: 31-12-2028 CSS-A14EY
CSS-A16EY
ISO Valid till: 19-06-2025 CSS-A10TY
CSS A12TY
CSS-A14TY
CSS-A16TY
CSS-B05PY
CSS-B06PY
CSS-B07PY
CSS-B08PY
CSS-B10EY
CSS-B12EY
CSS-B14EY
CSS-B16EY
CSS-B10TY

Decisions of 85th Meeting of MDB (21-03-2025) Page 3 of 138

 CSS-B12TY
CSS-B14TY
CSS-B16TY

Class-B

Shelf life: 5 Years

DRAP Application Receiving

Date:
24-12-2024

DRAP Fees:
Rs: 31,000/-
Challan No.
08312814138
Dated 20-12-2024

8. Gulfam Legal Manufacturer: Undis Deferred for the

Brothers SHAOXING UNDIS MEDICAL Disposable clarification of type
House No.1-C, TECHNOLOGY CO., LTD Endotracheal Tube of Endotracheal tube
Green Villa, Address: No.12 Yuexing (Cuffed/ Uncuffed)
Zaildar Park, Technology Park, No.11 Fanrong and codes as applied.
Ichra, Lahore, Road, Binhai New Area, 312366 Sizes: Codes:
Pakistan Shaoxing, Zhejiang Province, QCG-01 Series
PEOPLE’S REPUBLIC OF CHINA QCG-02 Series QCG-03 Series
ELI No.: ELI- QCG- 04 Series
00028 FSC Valid till: 17-06-2026 QCG-05 Series QCG-06 Series
QCG-07 Series QCG-08 Series
EC Valid till: 31-12-2028

ISO Valid till: 19-06-2025 Class-B

Shelf life: 5 Years

DRAP Application Receiving

Date:
24-12-2024

DRAP Fees:
Rs: 31,000/-
Challan No.
8485195899
Dated 20-12-2024

9. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Breast Coil.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor) Codes:
Pakistan. Philips Electronics Singapore Pvt
dS Breast 4598017288
Ltd
Coil 7ch 1X
50,000/- Address: 1.5T
622 Lorong 1 Toa Payoh, Singapore dS Breast 4598017299
319763. 7ch 1.5T 0X

Decisions of 85th Meeting of MDB (21-03-2025) Page 4 of 138

 LOA Valid till: 29th Aug 2029 dS Breast 4598017299
Netherlands FSC valid up to April 1, 7ch 3.0T 1X
2027 dS Breast 4598017298
ISO 13485 validity 01/02/2027 16ch 1.5T 8X
dS Breast 4598017298
16ch 3.0T 9X

10. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Anterior.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life:
Lahore. 54000
Punjab, (Distributor)
Model No:
Pakistan. Philips Electronics Singapore Pvt
Ltd
50,000/- Address: dS 45980173011
622 Lorong 1 Toa Payoh, Singapore Anterior X
319763. 1.5T

LOA Valid till: 29th Aug 2029 45980173012

dS X
Netherlands FSC valid up to April 1,
Anterior
2027
3.0T
ISO 13485 validity 01/02/2027

11. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Base.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Model No:
Pakistan. Philips Electronics Singapore Pvt
Ltd
50,000/- Address: dS Base 45980173005X
622 Lorong 1 Toa Payoh, Singapore 1.5T
319763.
45980173006X
th dS Base
LOA Valid till: 29 Aug 2029
3.0T
Netherlands FSC valid up to April 1,
2027
ISO 13485 validity 01/02/2027

12. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS HiRes Hand/Wrist.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models:
Pakistan. Philips Electronics Singapore Pvt
Ltd dS HiRes 4598017288
50,000/- Address: Hand/Wrist 6X
622 Lorong 1 Toa Payoh, Singapore

Decisions of 85th Meeting of MDB (21-03-2025) Page 5 of 138

 319763. 16Ch 1.5T

LOA Valid till: 29th Aug 2029 4598017288

dS HiRes 7X
Netherlands FSC valid up to April 1, Hand/Wrist
2027 16CH 3.0T
ISO 13485 validity 01/02/2027

13. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Flex.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models:
Pakistan. Philips Electronics Singapore Pvt
Ltd dS Flex-L 45980172993
50,000/- Address: 1.5T X
622 Lorong 1 Toa Payoh, Singapore
319763. dS Flex-L 45980172994
3.0T X
LOA Valid till: 29th Aug 2029
Netherlands FSC valid up to April 1,
2027 dS Flex-M 45980172995
ISO 13485 validity 01/02/2027 1.5T X

dS Flex-M 45980172996
3.0T X

dS Flex-S 45980172997
1.5T X
45980172998
dS Flex-S X
14. Matora Legal Manufacturer: Philips Approved
Digionics Pvt Philips Medical Systems Nederland dS FootAnkle Coil.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models:
Pakistan. Philips Electronics Singapore Pvt
Ltd dS 4598017288
50,000/- Address: FootAnkle 4X
622 Lorong 1 Toa Payoh, Singapore 16Ch 1.5T
319763.
dS 4598017288
LOA Valid till: 29th Aug 2029 FootAnkle 5X
Netherlands FSC valid up to April 1, 16CH
2027 3.0T
ISO 13485 validity 01/02/2027
dS 4598017293
FootAnkle 5X
Coil 8ch
1.5T

Decisions of 85th Meeting of MDB (21-03-2025) Page 6 of 138

15. Matora Legal Manufacturer: Philips Approved
Digionics Pvt Philips Medical Systems Nederland dS Head
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models:
Pakistan. Philips Electronics Singapore Pvt
Ltd dS Head 4598017301
50,000/- Address: 32ch 3.0T 3X
622 Lorong 1 Toa Payoh, Singapore
319763. dS Head 4598017300
1.5T 7X
LOA Valid till: 29th Aug 2029
Netherlands FSC valid up to April 1, 4598017300
2027 dS Head 8X
ISO 13485 validity 01/02/2027 3.0T

16. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS HeadNeck
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models:
Pakistan. Philips Electronics Singapore Pvt
Ltd dS 45980173009X
50,000/- Address: HeadNec
622 Lorong 1 Toa Payoh, Singapore k 1.5T
319763.
45980173010X
th
dS
LOA Valid till: 29 Aug 2029 HeadNec
Netherlands FSC valid up to April 1, k 3.0T
2027
ISO 13485 validity 01/02/2027

17. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Knee Coil.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models
Pakistan. Philips Electronics Singapore Pvt
Ltd dS Knee 4598017288
50,000/- Address: Coil 8ch 8X
622 Lorong 1 Toa Payoh, Singapore 1.5T
319763.
dS Knee 4598017300
LOA Valid till: 29th Aug 2029 Coil 16ch 2X
Netherlands FSC valid up to April 1, 1.5T
2027
ISO 13485 validity 01/02/2027

Decisions of 85th Meeting of MDB (21-03-2025) Page 7 of 138

18. Matora Legal Manufacturer: Philips Approved
Digionics Pvt Philips Medical Systems Nederland MICROSCOPY INGENIA.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models
Pakistan. Philips Electronics Singapore Pvt
45980172999X
Ltd
50,000/- Address:
622 Lorong 1 Toa Payoh, Singapore MICROSCOP
319763. Y 47MM,
INGENIA 1.5T
LOA Valid till: 29th Aug 2029
Netherlands FSC valid up to April 1, 45980179504X
2027 MICROSCOP
ISO 13485 validity 01/02/2027 Y 23MM,
INGENIA 1.5T

MICROSCOP 45980173001X
Y 23MM,
INGENIA 3.0T
45980179448X
MICROSCOP
Y 47MM,
INGENIA 3.0T
19. Matora Legal Manufacturer: Philips Approved
Digionics Pvt Philips Medical Systems Nederland dS Shoulder Coil.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models
Pakistan. Philips Electronics Singapore Pvt
Ltd dS 45980172
50,000/- Address: Shoulder 883X
622 Lorong 1 Toa Payoh, Singapore Coil 16Ch
319763. 1.5T

LOA Valid till: 29th Aug 2029 dS 45980172

Netherlands FSC valid up to April 1, Shoulder 883X
2027 Coil
ISO 13485 validity 01/02/2027 16CH
3.0T
45980173
dS 004X
Shoulder
Coil 8ch
1.5T
20. Matora Legal Manufacturer: Philips Approved
Digionics Pvt Philips Medical Systems Nederland dS Small Extremity
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,

Decisions of 85th Meeting of MDB (21-03-2025) Page 8 of 138

 Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor) Models
Pakistan. Philips Electronics Singapore Pvt
Ltd dS Small 45980172879
50,000/- Address: Extremity X
622 Lorong 1 Toa Payoh, Singapore 16Ch 1.5T
319763.
dS Small 45980172880
LOA Valid till: 29th Aug 2029 Extremity X
Netherlands FSC valid up to April 1, 16CH
2027 3.0T
ISO 13485 validity 01/02/2027

21. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS T/R Knee.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models
Pakistan. Philips Electronics Singapore Pvt
45980173003
Ltd dS T/R
50,000/- X
Address: Knee 16CH
622 Lorong 1 Toa Payoh, Singapore 3.0T
319763.

LOA Valid till: 29th Aug 2029

Netherlands FSC valid up to April 1,
2027
ISO 13485 validity 01/02/2027

22. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland dS Wrist Coil.
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-B
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Service Life: 10 years
Lahore. 54000
Punjab, (Distributor)
Models
Pakistan. Philips Electronics Singapore Pvt
Ltd dS Wrist 45980172934
50,000/- Address: Coil 8CH X
622 Lorong 1 Toa Payoh, Singapore 1.5T
319763.

LOA Valid till: 29th Aug 2029

Netherlands FSC valid up to April 1,
2027
ISO 13485 validity 01/02/2027

23. Matora Legal Manufacturer: Philips Approved

Digionics Pvt (LEGAL MANUFACTEURER) Philips CT Big Bore
Ltd 7-A, Aziz 1. Philips Medical Systems
Avenue, Canal Nederland B.V Class-C
Bank Road, Address:
Gulberg V, Veenpluis 6 5684PC Best, Shelf life:

Decisions of 85th Meeting of MDB (21-03-2025) Page 9 of 138

 Lahore. 54000 Netherlands
Punjab, 2. Philips Healthcare Model:
Pakistan. (Suzhou) Co., Ltd 728242
Address:
62,000/- No.258, ZhonYuan Road
Suzhou Industrial Park
215024Suzhou, Jiangsu
Province PEOPLE
REPUBLIC OF CHINA

(Distributor)
Philips Electronics Singapore Pvt
Ltd
Address:
622 Lorong 1 Toa Payoh, Singapore
319763

LOA Valid till: 29th Aug 2029

Netherlands FSC valid up to 04-06-
2027
ISO 13485 validity 01/02/2027

24. Matora Legal Manufacturer: Philips Approved

Digionics Pvt Philips Medical Systems Nederland 3D-RA
Ltd 7-A, Aziz B.V
Avenue, Canal Address: Class-C
Bank Road, Veenpluis 6 5684PC Best,
Gulberg V, Netherlands Shelf life:
Lahore. 54000
Punjab, (Distributor)
Pakistan. Philips Electronics Singapore Pvt Model No:
001102
Ltd
62,000/- Address:
622 Lorong 1 Toa Payoh, Singapore
319763.

LOA Valid till: 29th Aug 2029

Netherlands FSC valid up to May 26,
2025
ISO 13485 validity 01/02/2027

25. M/s Mian Legal Manufacturer: LAURALENS Approved subject to

Enterprises M/s Laurus Optics Ltd. (Hydrophilic Acrylic Intraocular submission of valid
Hong Kong Unit 702, 7/F, Tower 2, Lens ISO 13485 and Ce
Office No.UG- Ever Gain Plaza, No.88 Container Hydrophilic Aspheric Acrylic certificate.
400, Deans Port Road, Kwai Chaung, NT, Hong Intraocular Lens) The firm will submit
Trade Center, Kong. separate application
Peshawar Cantt Class C and fee for HA80R
25000 Pakistan LOA validity 06-02-2030 Hydrophilic Acrylic
FSC issuance 17-09-2023 Shelf Life: 5 Years Intraocular Lens
ELI-00507 ISO 13485 validity
26-08-2024 Codes:
CE validity 27-05-2024 HA80A
Hydrophilic Aspheric Acrylic
Intraocular Lens
HA80R
Hydrophilic Acrylic Intraocular Len

Decisions of 85th Meeting of MDB (21-03-2025) Page 10 of 138

26. M/s Chemical Legal Manufacture: D-10 Hemoglobin testing system Approved.
House situated Biorad laboratories Inc.
at 4000 Alfred nobel drive Hercules Class B
CA, 94547, USA
6-C sikandar Service life: 07-years
Manufacturing Site(s):
Malhi road
Codes/Sizes (if any) (catalogue
Canal park BIO-RAD 7-rue-de madrid 67300, number 12010405 (D-10
Gulberg-III schiltigheim France. HEMOGLOBIN
Lahore LOA Validity: 31/12/2027 TESTING SYSTEM
ELI-00156. FSC: 220-0600 (D-10
FSC of Reference Country France) Rack loader )
R&I Details Validity: 20/09/2025
27-01-2020
ISO 13485:
Fee Challan No. Validity: 11-12-2027
1928856
dated
27-01-2020
27. M/s Chemical Legal Manufacture: Liquichek Urine Approved;
Hose situated at Biorad laboratories Inc. Control subject to provisions
Manufacturing Site(s): of valid FSC and
6-C sikandar Class B original fee Challan
Malhi road Bio-rad laboratories Inc. as the attached fee slip
Canal park 9500 jeronimo road, Irvine, CA, shelf life: is not legible.
Gulberg-III liquichek urine chemistry control
USA 92618.
Lahore (397, 398, 395x)
ELI-00156 - shelf life is 720-days
LOA Validity: 31/12/2025
R&I Details liquichek urinalysis control
FSC of USA Validity: 09/02/2025 (435, 436, 437)
09-04-2020
ISO 13485: shelf life: 900-days
Fee Challan
Validity: 17-05-2025
No.2005629
dated 08-04-
2020
28. M/s Chemical Legal Manufacture: TOX/See Drug screen test-PPX Approved.
Hose situated at (ABON Biopharm (194-5204)
(Hangzhou) Co. Ltd.
6-C sikandar Class A
Address: #198 , 12th street east,
Malhi road Claimed Shelf life: 24-months
Hongzhou, economic and
Canal park
Technological department area,
Gulberg-III
310018, Hangzhou,
Lahore
Republic of China
Distributor name:
ELI-00156 (authorized distributor of ABON
(manufacturer) products in USA)
R&I Details Biorad laboratories Inc.
25/02/2025
Address: 4000 Alfred
Fee Challan No. Nobel drive Hercules CA, USA
27885372 94547. )
Manufacturing Site(s):
dated 08- (ABON Biopharm
012025 (Hangzhou) Co. Ltd.
Address: #198 , 12th street east,
Hongzhou, economic and
technological

Decisions of 85th Meeting of MDB (21-03-2025) Page 11 of 138

 department area,
310018, Hangzhou,
Republic of China)
FSC USA Validity: 13/12/2025
LOA Validity: 31/12/2027
29. Taj Diagnostics Legal Manufacturer: Brand Name: Approved.
Shop No. G-166, INTEC
Maryam Market, INTEC PRODUCTS ,INC. 332 (Generic name)
M.A. Jinnah Xinguang RAPID ANTI
Road, Sadder, Road, Xinyang H. Pylori test
Karachi Email Ind, Haicang, Xiamen, P.R. CHINA
Address : 361022 . Class B

(ELI-00589) FSC: CHINA Claimed Shelf Life: 02-years

Validity:15-JAN-2027 Codes/Sizes:
Date of R&I FSC of BELGIUM ITP10002-DS50
19-AUG-2022 Validity: 15-JAN-2027 ITP10002-TC40
LOA ITP10212-DS50 ITP10212-TC40
Validity: 23-MARCH-2027
ISO 13485
Validity: 30-07-2027

30. Taj Diagnostics Legal Manufacturer: INTEC ONE STEP Pregnancy Approved.
Shop No. G-166, (HCG)
Maryam Market, INTEC PRODUCTS ,INC. 332 Test
M.A. Jinnah Xinguang
Road, Sadder, Road, Xinyang Class B
Karachi Email Ind, Haicang, Xiamen, P.R. CHINA
Address : 361022 . Claimed Shelf Life: 02-years

(ELI-00589) FSC: CHINA Codes/Sizes:

Validity: 21-NOV-2026
Date of R&I FSC of BELGIUM ITP04002-DS50
19-AUG-2022 Validity: 15-JAN-2027
LOA ITP04002-TC40
Validity: 23-MARCH-2027
ISO 13485
Validity: 30-07-2027
31. Taj Diagnostics Legal Manufacturer: INTEC Approved.
Shop No. G-166, (Generic name)
Maryam Market, INTEC PRODUCTS ,INC. 332
M.A. Jinnah Xinguang ONE STEP Multi-10 DOA
Road, Sadder, Road, Xinyang Test
Karachi Email Ind, Haicang, Xiamen, P.R. CHINA
Address : 361022 .
Class B
(ELI-00589) FSC: CHINA Claimed Shelf Life: 02-years
Validity: 21-NOV-2026
Date of R&I FSC of BELGIUM Code: ITP-06109-DT10
19-AUG-2022 Validity: 15-JAN-2027
LOA
Validity: 23-MARCH-2027
ISO 13485
Validity: 30-07-2027
32. M/s Pulse Argon Medical Devices, Brand name: Approved;
Surgicals Inc. UltraCoreTM Biopsy subject to provisions
Address: Suite Address: 1445 Flat Needle of valid ISO-13485
No. 113, First Creek road, Athens, Texas 75751 and codes.

Decisions of 85th Meeting of MDB (21-03-2025) Page 12 of 138

 floor, Almas USA Generic name: Biopsy needle
height, 190/1,
Block 2 FSC validity: Specification/sizes:
PECHS,
Karachi, 75400 15-05-2026 As per FSC
Pakistan LOA validity:
Class: B
License No. 23-06-2028
ELI-00578 ISO 13485 Claimed Shelf Life: 05-years
Validity: 08-04-2025
Receipt No.
014453765674
33. M/s Pulse Argon Medical Devices, ProMagTM Ultra Approved;
Surgicals Inc. subject to provisions
Address: Suite Address: 1445 Flat Automatic Biopsy Instrument of valid ISO-13485
No. Creek road, Athens, Texas 75751 Specification/sizes: and differential fee
113, First floor, USA 7675 Pro-MagTM Ultra for Class-B.
Almas height, Automatic Biopsy
190/1, FSC validity: Instrument
Block 2
15-05-2026
PECHS, Class: A
Karachi, 75400
Pakistan LOA validity: Shelf life:
License No. 23-06-2028 They are reusable devices that are
ELI-00578 ISO 13485 sold non-sterile with a
Validity: 08-04-2025 manufacturing date but not a shelf
life.
Receipt No.
14884945400

34. M/s Pulse Argon Medical Devices, Brand name: Approved;

Surgicals Inc. Address: 1445 Flat Creek Pro-MagTM subject to provisions
Address: Suite road, Athens, Texas 75751 USA Ultra Biopsy of valid ISO-13485
No. 113, First Needle and codes.
floor, Almas FSC validity:
height, 190/1, 15-05-2026
Block 2 Specification/sizes:
PECHS, As per FSC
Karachi, 75400 LOA validity:
Pakistan 23-06-2028 Class: B
License No. ISO 13485
Claimed Shelf Life: 05-years
Validity: 08-04-2025
ELI-00578
Receipt No.
048656998797

35. M/s Pulse Argon Medical Devices, Argon Co-Axial introducer needle Approved;
Surgicals Inc. Address: 1445 Flat subject to provisions
Address: Suite Creek road, Athens, Texas 75751 Specification/sizes: of valid ISO-13485.
No. 113, First USA MCXS1610BP
floor, Almas FSC validity: MCXS1615BP
height, 190/1, 15-05-2026 MCXS1810BP
Block 2 MCSX1815BP
LOA validity:
PECHS, MCSX1820BP
Karachi, 75400 23-06-2028
ISO 13485 Class: B
Pakistan
Validity: 08-04-2025 Claimed Shelf Life: 05-years
License No.
ELI-00578
Receipt No.

Decisions of 85th Meeting of MDB (21-03-2025) Page 13 of 138

 74473039
36. M/s Pulse Argon Medical Devices, TravelerTM Approved;
Surgicals Inc. Address: 1445 Flat Portal Vein subject to provisions
Address: Suite Creek road, Athens, Texas 75751 Access Set of valid ISO-13485
No. 113, First USA and codes.
floor, Almas Generic name:
FSC validity:
height, 190/1, Stylet/ Needle portal Vein Access
15-05-2026 Set
Block 2
LOA validity:
PECHS, Class: B
Karachi, 75400 23-06-2028
Pakistan ISO 13485 Claimed Shelf Life: 03-years
Validity: 08-04-2025
License No.
ELI-00578
Receipt No.
12718050
37. M/s Pulse Argon Medical Devices, Scorpion Portal Vein Access Set Approved;
Surgicals Inc. Address: 1445 Flat subject to provisions of
Creek road, Athens, Texas 75751 Specification/sizes: valid ISO-13485 and
Address: Suite
No. 113, First USA TPS005 Sorpion submit fee for TPS006
floor, Almas FSC validity: Portal Vein Access Set. Scorpion X Portal
height, 190/1, TPS006 Vein Access Set
15-05-2026
Block 2 Scorpion X Portal Vein Access Set
LOA validity:
PECHS, Class: B
Karachi, 75400 23-06-2028
Pakistan ISO 13485 Claimed Shelf Life: 03-years
Validity: 08-04-2025
License No.
ELI-00578
Receipt No.
17129064300
38. M/s Hearing Legal Manufacturer: Sivantos A&M STF P T1 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, Generic Name: Hearing Instrument subject to provisions
Centre, 2- 91058 Erlangen, Germany BTE (Behind-The-Ear) of valid FSC of
Kausar Arcade Manufacturing Site (s): Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street Class: B or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Shelf Life: N/A
Canntt LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10940423
R&I details FSC:
Country of Singapore
06/03/2025
Validity: 13/01/2027
ISO 13485:
Fee Challan
Validity: 30/11/2025
No:3205942148
0
Dated:
28/02/2025
39. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M STF P T3 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10940420, 10940421

Decisions of 85th Meeting of MDB (21-03-2025) Page 14 of 138

 FSC:
R&I details Country of Origin
Validity: 13/01/2027
06/03/2025
ISO 13485:
Validity: 30/11/2025
Fee Challan No:
03036486
Dated:
28/02/2025
40. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M STF XP T3 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10941683, 10941684
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
25162451753

Dated:
28/02/2025
41. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM P P4 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10940415, 10940414
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
14632199563

Dated:
28/02/2025
42. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM XP P4 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10941678, 10941677
FSC:
R&I details Country of Origin

Decisions of 85th Meeting of MDB (21-03-2025) Page 15 of 138

 06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
2454271219

Dated:
28/02/2025
43. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, CUSTOM P4 subject to provisions
Centre, 2- 91058 Erlangen, Germany of valid FSC of
Kausar Arcade Manufacturing Site (s): Generic Name: Hearing Instrument Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street Customized Model or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Class: B
Canntt
LOA: Shelf Life: N/A
ELI-01267 Validity: 30/06/2028
FSC: Codes/Sizes: 10957883, 10957884,
R&I details Country of Origin 10957887, 10957888, 10957889,
06/03/2025 Validity: 13/01/2027 10957890, 10957893,
ISO 13485:
Fee Challan No: Validity: 30/11/2025
709368750

Dated:
28/02/2025
44. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM P P6 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10951357, 10951334
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
70534346

Dated:
28/02/2025
45. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM XP P6 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10941675, 10941674
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:

Decisions of 85th Meeting of MDB (21-03-2025) Page 16 of 138

 Fee Challan No: Validity: 30/11/2025
15182979

Dated:
28/02/2025
46. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, CUSTOM P6 a subject to provisions
Centre, 2- 91058 Erlangen, Germany of valid FSC of
Kausar Arcade Manufacturing Site (s): Generic Name: Hearing Instrument Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street Customized Model or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Class: B
Canntt
LOA: Shelf Life: N/A
ELI-01267 Validity: 30/06/2028
FSC: Codes/Sizes: 10957882, 10957881,
R&I details Country of Origin 10957880, 10957879, 10957876,
06/03/2025 Validity: 13/01/2027 10957875, 10957891,
ISO 13485: N/A
Fee Challan No: Validity: 30/11/2025
5890940111

Dated:
28/02/2025
47. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM P P8 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10956382, 10956375
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
53637943754

Dated:
28/02/2025
48. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM XP P8 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): BTE (Behind-The-Ear) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10957913, 10957912
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
00645933403

Decisions of 85th Meeting of MDB (21-03-2025) Page 17 of 138

 Dated:
28/02/2025
49. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM RIC P8 Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, subject to provisions
Centre, 2- 91058 Erlangen, Germany Generic Name: Hearing Instrument of valid FSC of
Kausar Arcade Manufacturing Site (s): RIC (Receiver-in-Canal) Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street or CE certificate.
Sindbad Kalma #08-08 Class: B
Chowk, Multan Singapore 539775
Canntt Shelf Life: N/A
LOA:
ELI-01267 Validity: 30/06/2028 Codes/Sizes: 10956319, 10956318
FSC:
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
329544725

Dated:
28/02/2025
50. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, CUSTOM P8 subject to provisions
Centre, 2- 91058 Erlangen, Germany of valid FSC of
Kausar Arcade Manufacturing Site (s): Generic Name: Hearing Instrument Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street Customized Model or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Class: B
Canntt
LOA: Shelf Life: N/A
ELI-01267 Validity: 30/06/2028
FSC: Codes/Sizes: As per FSC.
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
6967322998

Dated:
28/02/2025
51. M/s Hearing Legal Manufacturer: Sivantos Brand Name: A&M XTM IF CIC Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, P4 subject to provisions
Centre, 2- 91058 Erlangen, Germany of valid FSC of
Kausar Arcade Manufacturing Site (s): Generic Name: Hearing Instrument Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street CIC (Completely-in-the-Canal) or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Class: B
Canntt
LOA: Shelf Life: N/A
ELI-01267 Validity: 30/06/2028
FSC: Codes/Sizes: 10943604, 10943603.
R&I details Country of Origin
06/03/2025 Validity: 13/01/2027
ISO 13485:
Fee Challan No: Validity: 30/11/2025
20810397

Dated:
28/02/2025

Decisions of 85th Meeting of MDB (21-03-2025) Page 18 of 138

52. M/s Hearing Legal Manufacturer: Sivantos A&M XTM IF ITC P4. Approved;
Healthcare GmbH, Henri-Dunant-Strasse 100, Generic Name: Hearing Instrument subject to provisions
Centre, 2- 91058 Erlangen, Germany IF ITC (Ideal For First-Time-Users) of valid FSC of
Kausar Arcade Manufacturing Site (s): Germany or any RRA
opp Hotel Sivantos Pte Ltd, 18 Tai Seng Street Class: B or CE certificate.
Sindbad Kalma #08-08
Chowk, Multan Singapore 539775 Shelf Life: N/A
Canntt LOA: Codes/Sizes: 10943610, 10943609
Validity: 30/06/2028
ELI-01267 FSC:
Country of Origin
R&I details Validity: 13/01/2027
06/03/2025 ISO 13485:
Fee Challan No: Validity: 30/11/2025
8512959117
Dated:
28/02/2025
53. M/s. Uniprom Legal Manufacturer: Brand Name Approved; Subject to
Healthcare M/s Amity International, U.K. Virusolve+™ Provisions of Valid
Address: Libra House, West Street, Generic name (Didecyldimethyl FSC of UK and ISO
Address: L-151, 13485
Worsbrough ammonium chloride)
2nd Floor, 13- Certificate.
Dale, Barnsley, S70 5PG. UK
G, Sehba The firm will submit
FSC: Class: Class B
Akhtar Road, separate application
Country of Origin: UK
Gulshan e Iqbal,
Karachi.
Validity: 14th September 2024 Shelf Life: Shelf life of the product is and fee for
three years from date of manufacture Virusolve+™
when stored unopened and as Lavender.
LOA
ELI-00286 Validity: 31 December directed.
2025
Date of R&I ISO 13485 Codes/Sizes:
17th October Validity: 14th September 2024 1.Virusolve+ High Level Medical
2022 Surface Disinfectant –125 ml

2.Virusolve+ High Level

Medical Surface Disinfectant –250
ml
54. M/s. Uniprom Legal Manufacturer: Brand Name Approved; Subject to
Healthcare M/s Amity International, U.K. VIRUSOLVE+ EDS Provisions of Valid
Generic name: (Didecyldimethyl FSC of UK and ISO
Address: L-151, 13485
Address: Libra House, West Street, ammonium chloride)
2nd Floor, 13- Worsbrough Certificate.
G, Sehba
Dale, Barnsley, S70 5PG. UK Class : Class C
Akhtar Road,
Gulshan e Iqbal,
Karachi. FSC: Shelf Life: 3 Years
Country of Origin: UK
Validity: 14th September 2024 Codes/Sizes:
ELI-00286
LOA • VIRUSOLVE+ EDS
Date of R&I Validity: 31 December 125ml
17th October 2025 • VIRUSOLVE+ EDS
2022 ISO 13485 250ml
Validity: 14th September 2024 • VIRUSOLVE+ EDS
1Liter

55. M/s Jasani Legal Manufacturer: RT-3100 Refractor Approved; Subject to

Scientifics Nidek Co. LTD, (Refractometer) Provisions of Valid
SC-45, Marium Address: 34-14 FSC of RRA and ISO

Decisions of 85th Meeting of MDB (21-03-2025) Page 19 of 138

 Square, Maehama, Hiroishi-cho, Gamagori, Class-A 13485.
chandni Aichi 4430038 Japan.
Chowk,
FSC Validity Date: 13/09/2024 Shelf life: N/A
Stadium road,
Karachi, GMDN Codes: 35299
LOA Validity:
74800, ELI- 31/12/2027 Codes and Sizes as per FSC
000416.
R&I:
03/11/2020
Fee Slip No:
2006296
Fee Submission
Date:
08/10/2020
56. M/s Muller & Legal Manufacturer: SILESSE Approved.
Phipps Pakistan ConvaTec Advance barrier film Codes
(Pvt.) Limited First 420790
Limited Uzma Avenue Deeside Class A
Court Main Industrial Park Deeside, Shelf Life:04-Years
Clifton Road, Flintshire, CH5
Karachi. 2NU, UK,
License No. FSC Issue: 20-10-2024
ELI- LOA
00030 Validity: 28-01-2026
ISO-13485
Validity: 30-01-2026
57. M/S ORBIT SHIJIAZHUANG HIPRO Approved;
DIAGNOSTIC Hipro Bio technology Automatic subject to provisions
S Co., ltd Immunoassay of valid FSC of any
Address of (Manufacturing System RRA or CE
Importer: site) No. 3 Building, certificate.
403, PLAZA Fangyi Tech. Park, Class B
55, BEHRIA No. 313 Zhujiang
TOWN-IV, RD, Shijiazhuang, Shelf Life:
CIVIC P.R. CHINA 05 Years
CENTRE LOA
ISLAMABAD. Valid till 01-04-2026 Code: 57871
PAKISTAN FSC: China
Validity: 24-11-2025 Specification Model: HP-AFS/1
ELI-00630 ISO 13485 Analyzer
Validity: 16 July 2026
Date of R& I
13 Sep 2021
58. Aston Medical Manufacturer Name: Chalice Paragon Oxygenators with Approved.
Pakistan Medical Ltd Accessories
4-A, 4TH Floor Address: Manton Class B
38C Bukhari Wood Enterprise
Commercial Park, Workshop Shelf Life: 02 YEARS
Lane 8 Phase Nottinghamshire
6 S80 2RS United Codes/Sizes:
Kingdom. XCMOPI260MN - Paragon
DHA Karachi
Adult Midi Integrated
ELI-00797 Distributed by: Aston Oxygenator with Micronet Filter
Med UK XCMOPI260PP - Paragon
Address: 18 St James Adult Midi Integrated
Road, Purley, Surrey Oxygenator
CR8 2DL UK

Decisions of 85th Meeting of MDB (21-03-2025) Page 20 of 138

 Date of R&I
10-02-2025
FSC: Country of Origin UK
Validity: 27-04-2028
LOA
Validity: 27-08-2027
ISO-13485
Validity: 09-11-2025.
59. Musaji Adam & Legal Manufacturer: Approved.
Sons Trek diagnostic systems, limited.
Address:C-285, Manufacturing Site:
Block 10, Units 17-19,Willard Way, Birches
Federal B Area, Industrial Estate, East Grinstead,
Karachi. RH 191 XZ, United Kingdom. Sensititre™ YeastOne
Establishment FSC: Product code: YO10 Class:B
License: Country of Origin: Shelf Life:24 Month
ELI 00239. United Kingdom
Date of R&I Validity: May,2025
29-jan-2021 LOA
Validity:31-12-2025
ISO 13485
Validity: 06-11-2025
60. Name of Firm Legal Manufacture Name of Medical Device Approved;
(s) Manufacturing Site subject to provisions
SFRI SAS of valid ISO.
Briogene Pvt Hemix 3-60
Ltd, Lieu-dit Berganton – 33127 Saint automated high quality hematology
Jean d’lllac analyzer
196-A, Sindhi France
Muslim Class B
Cooperative LOA
Housing Expiry Date: 30th June 2025 Shelf Life:
Society,
Shahrah-e- FSC : France Codes:
Faisal, Date of Issuance: 21-July-2022
Karachi Nam Code Shelf
ISO 13485 e Life
(ELI-00015) Expiry: 27-11-2023 Hem A021 36
ix 3- 4 Mont
Date of 60 hs
submission: 18th Anal
Oct 2023 yzer
SFRI HSD3 36
Fee submitted: Dilu 26 Mont
PKR 25,000/- ent hs
(Challan # 3-60
8529460653) SFRI HSL3 24
Tracking id: Lyse 06 Mont
87W-ZTH- 3-60 hs
YMR4 SFRI HSC3 24
Clea 06 Mont
nEZ hs
3-60
SFRI HSC1 12
Clair 06 Mont
3-60 hs
61. Name of Firm Legal Manufacture Name of Medical Device Approved;
(s) Manufacturing Site subject to provisions

Decisions of 85th Meeting of MDB (21-03-2025) Page 21 of 138

 Thermo Fisher Scientific Oy, of differential fee of
Briogene Pvt Ratastie 2,FI-01620 Vantaa, Finland Clinical Chemistry class-B.
Ltd, LOA (Immunochemistry)
Expiry Date: 27th January 2026
196-A, Sindhi Class A
Muslim FSC Country of Origin: Finland
Cooperative Date of Issuance: 12-Sep-2024 Shelf Life:
Housing
Society, FSC Reference Country: Australia Codes:
Shahrah-e- Date of Issuance: 27-Feb-2023
Faisal, ISO 13485 Nam Cod She
Karachi Expiry: 31-3-2027 e e lf
Lif
(ELI-00015) e
Hea 9816 18
Date of moly 59 Mo
submission: 7th zing nth
Jan 2025 Reag s
ent
Fee submitted:
PKR 6,000/-
Challan #
15947038279
Tracking id:
UYW-LPY-
UPLA
62. Name of Firm Legal Manufacture Name of Medical Device Approved.
(s) Manufacturing Site
Thermo Fisher Scientific Oy,
Briogene Pvt Ratastie 2,FI-01620 Vantaa, Finland Clinical Chemistry
Ltd, LOA (Electrolyte Electrodes)
Expiry Date: 27th January 2026
196-A, Sindhi Class B
Muslim FSC Country of Origin: Finland
Cooperative Date of Issuance: 12-Sep-2024 Shelf Life:
Housing
Society, FSC Reference Country: Australia Codes:
Shahrah-e- Date of Issuance: 27-Feb-2023
Faisal, Name C Shelf
Karachi ISO 13485 o Life
Expiry: 31-3-2027 d
(ELI-00015) e
Potass 9 18
Date of ium 8 Mont
submission: 7th (k+) 1 hs
Jan 2025 Micro 5
Volu 9
Fee submitted: me 3
PKR 31,000/- Electr
Challan # ode
34719978117 Chlori 9 Mont
Tracking id: de 8 hs
95P-5N4-G1M8 (Cl-) 1
Micro 5
Volu 9
me 6
Electr
ode
Sodiu 9 Mont

Decisions of 85th Meeting of MDB (21-03-2025) Page 22 of 138

 m 8 hs
(NA+ 1
) 5
Micro 9
Volu 4
me
Electr
ode
63. Name of Firm Legal Manufacture Approved, subject to
(s) Manufacturing Site ODAK OBG Forward group provisions of
ISLAB Biyoteknoloji differential fee of
Briogene Pvt Class B class-D.
Ltd, Tibbi Malzeme Saglik Hizmetleri
Sanayi ve Ticaret Anonim Sirketi. Shelf Life:
196-A, Sindhi Kaynarca Mh. Kadirli Sk No:10b/D
Muslim Blok Pendik Codes:
Cooperative Turkey
Housing Name Co Shel
Society, LOA de f
Shahrah-e- Expiry Date: 13th August 2026 Life
Faisal, ODA O 13
Karachi FSC Country of Origin: Turkey K B Mon
Validity: 22-Dec-2026 OBG G ths
(ELI-00015) Forw F
EC Certificates ard G
Date of FQA group 1-
submission: 4th Validity: 26-May-2025 1 50
February 2025 Design Examination ODA O 13
Validity: 26-May-2025 K B Mon
Fee submitted: OBG G ths
PKR 31,000/- ISO 13485 Forw F
Challan # Expiry: 8-7-2025 ard G
4118038628 group 2-
Tracking id: 2 50
4EX-XW8-
6YBW
64. Name of Firm Legal Manufacture Approved, subject to
(s) ODAK OBG Forward & Reverse provisions of
Manufacturing Site group differential fee of
Briogene Pvt ISLAB Biyoteknoloji class-D.
Ltd, Class B
Tibbi Malzeme Saglik Hizmetleri
196-A, Sindhi Sanayi ve Ticaret Anonim Sirketi. Shelf Life: 13 Months
Muslim Kaynarca Mh. Kadirli Sk No:10b/D
Cooperative Blok Pendik Codes: OBGFRG-50
Housing Turkey
Society,
Shahrah-e- LOA
Faisal, Expiry Date: 13th August 2026
Karachi
FSC Country of Origin: Turkey
(ELI-00015) Validity: 22-Dec-2026

Date of EC Certificates
submission: 4th FQA
February 2025 Validity: 26-May-2025
Design Examination
Fee submitted: Validity: 26-May-2025
PKR 31,000/-

Decisions of 85th Meeting of MDB (21-03-2025) Page 23 of 138

 Challan # ISO 13485
793088193072 Expiry: 8-7-2025
Tracking id:
Y7N-TV8-
YPAH

65. Siemens Legal Manufacturer: Symbia Evo + Excel Approved, subject to

Healthcare Siemens Medical Solutions USA gamma camera provisions of valid
Private Limited; Inc Class B FSC of USA or any
th Floor, State 2501 N. Barrington Road RRA or CE
Life Building, Hoffman certificate.
15-A, Davis Estates, IL, 60192, USA Shelf Life: Not applicable. (Made
Road, Lahore Manufacturing Site: to order)
ELI-00146 Private Limited Siemens Medical
1 R&I Details: Solutions USAInc Code/Sizes: 10910500
9 11006983
19th December 15-A, 2501 N. Barrington Road
10910501
Davis2024
Road, Lahore Hoffman Estates, IL, 60192, USA LoA:
Validity: 30 September 2029
FSC:
Country of origin: USA
Validity: N/A
EC Certificate:
Validity: N/A

ISO-13485:
Validity: 05 June 2027
66. M/s S. Ejazuddin Legal Manufacturer: Dade Owren’s Veronal Buffer Approved
& M/s Siemens Healthcare
Co., Diagnostics Products Class A
237-B, Block II, GmbH Emil-von-
PECHS, Behring-Straße 76 35041 Shelf Life: 24 months
Shahrahe- Marburg Germany
Quaideen, FSC:Germany months
Karachi, Issue Date: 19.01.2023 Codes: OQAA33
Pakistan (No Expiry)
LOA
(ELI-00078) Validity: 13.12 2025
R & I Date: ISO
26.05.2023 Validity: 15.08.2027
Paid Fee Challan
No.: 830212308
Dt: 22.05.2023
67. M/s S. Ejazuddin Legal Supplementary Approved
& Manufacturer: Reagents for
Co., M/s Siemens Coagulation
237-B, Block II, Healthcare Analyzers
PECHS, Diagnostics Products GmbH Emil-
Shahrahe- von-Behring-Straße 76 35041 1. Product name: Calcium
Quaideen, Marburg Germany Chloride Solution Product code:
Karachi, ORH037
Pakistan FSC: Germany issue Date:
19.01.2023 Class A
(ELI-00078) LOA Validity:
13.12.2025 Shelf Life: 60
R & I Date: months
26.05.2023 ISO Validity: Sizes as per
15.08.2027 FSC
Paid Fee Challan

Decisions of 85th Meeting of MDB (21-03-2025) Page 24 of 138

 No.
115596918894
Dt: 22.05.2023
68. Rech M/s Beijing Medkon Medical Medkon (Pulse Lavage System) Approved, subject to
International, Devices Co, Ltd Floor 1 and 2 provisions of valid
Karachi Building 1, Floor Class B FSC of any RRA/CE
Address of 1and 2 Building 5, 8 Yunteng Rd., certificate and codes.
Importer Miyun Economic Development Shelf Life: N/A
247/B, Block 6 Zone, Miyun District, 101500 Sizes as per FSC
PECHS Beijing, P.R. China.
Shahrah-e- Fsc: China (18-03-2026)
Faisal Karachi. LOA-
Date of R& I Validity- 20th October 2025
Submission ISO 13485-
date: 6-March- Validity 29-1-2027
2024
Fee
Rs 25,000, fees
challan NO;
82579984739
69. Rech (LEGAL MANUFACTEURER) Surgical Instrument Deferred for
International, Changzhou Kanghui Medical Class-A provision of complete
Karachi Device Innovation Co., Ltd description and
Address of Complete Address: No.11, north Shelf Life: N/A classes of the
Importer Changjiang Road, xinbei zone, products mentioned,
247/B, Block 6 Changzhou Brand name and
PECHS 213022, Jiangsu, P.R. China instrumeents applied.
Shahrah-e- Fsc: China Nov,2024
Faisal Karachi. FSC 2: Germany, Expiry Not
Date of R& I mentioned
Submission Marketing Authorization Letter:
date: 6-March- LOA-Validity- Dec,2026
2024
ubmission date: 13485) ISO 13485- Validity
17, Aug-2020 June,2026.
Fee Rs 5,000
70. M.M Legal Manufacturer: Abm disposable semi-automatic Approved subject to
BROTHERS MEDPLUS INC biopsy provision of FSC of
shop no. 36 Manufacturing Site: add 4th floor, Needle RRA/CE and Valid
madina centre building 6 no.586 zhongshun road, ISO-13485.
kutchi gali zhongcun panyu district, Class B
no.1 denso hall Guangzhou china. Shelf Life: 5 YEARS
Karachi. LOA: Codes/Sizes:
Original Agency agreement
ELI-00651 Validity: MARCH, 2029 Code Size

Date of R& I FSC: CHINA 15011 14G*10

30/12/2024 4107 CM
Fee Rs. 31,000/ 15011 14G*15
through slip no. 4157 CM
91694250, dated 15011 14G*20
20/12/2024 4207 CM
15011 16G*10
6107 CM
15011 16G*15
6157 CM
15011 16G*20
6207 CM

Decisions of 85th Meeting of MDB (21-03-2025) Page 25 of 138

 15011 16G*25
6257 CM
15011 18G*10
8107 CM
15011 18G*15
8157 CM
15011 18G*20
8207 CM
15011 18G*25
8257 CM
71. M/s. Unique Legal Manufacturer: OPTIANO-55 Approved subject to
Visual System NEO VISION CO., LTD. provision of FSC of
L-18, Block-17, Head Office : Generic Name RRA/CE and Valid
Gulshan-e- Heungdeokjungang-ro, NEO CLEAN ISO-13485.
Iqbal, Giheung-gu, Yongin-si, (Additional name: OPTIANO-55)
Karachi, Gyeonggi-do 120 U- Soft Contact Lens
Pakistan TOWER 17F, Korea Factory:
129-1, HS CODE
ELI-00449 Donghwagongdan-ro, Munmak- 9001.3000
eup, Wonjusi, Gangwon-do, Korea
Class: B
FSC: (EXPORT ONLY) KOREA
Issued on Sep 2, 2024 VALIDTY Shelf Life: 5 Years
LOA July 15, 2024
ISO 13485
VALIDITY: 25-08-2027

72. M/s. Allmed Legal KARL STORZ Retaining Systems to Approved subject to
Solutions Manufacturer: hold instruments. provsion of
Address: KARL STORZ SE & CO. KG instruments involved
A-21/3, KDA Germany Class A and codes.
Scheme No.1 Address: Dr.-
(ext) Stadium Karl-Storz- StraBe 34 78532 Shelf Life: N/A
Road, Tuttlingen, Germany
Karachi FSC: Germany Validity: Not Codes / Sizes:
mentioned issued in Oct. 2022 As per FSC.
ELI:00029
LOA
R&I details Validity: 31/12/2025
Date: ISO 13485
06/02/2023 VALIDITY: 31-05-2025
Slip no.
95489196885
Rs. 5000/-

73. M/s. Allmed Legal Manufacturer: KARL STORZ Sheaths Trocars Approved sheaths
Solutions KARL STORZ SE & CO. KG (Sheaths, Trocars and accessories subject to provision
Address: Germany (sterile/non-sterile)) of codes for sterile.
A-21/3, KDA Apply separately for
Scheme No.1 Address: Dr.-Karl-Storz- Class A non sterile and trocar
(ext) Stadium StraBe 34 78532 Tuttlingen,
Road, Germany Shelf Life: N/A
Karachi
FSC: Germany Validity: Not Codes / Sizes:
ELI:00029 mentioned, issued
in Oct. 2022
R&I details LOA

Decisions of 85th Meeting of MDB (21-03-2025) Page 26 of 138

 Date: Validity: 31/12/2025
06/02/2023 ISO 13485
Slip no. VALIDITY: 31-05-2025
916963722024
Rs. 5000/-
74. Musaji Adam & Legal Manufacturer: Remel Europe Brucella Abortus Approved. Firm
Sons Limited Agglutinating Serum submitted FSC of
Address:C-285, R30164801 UK.
Block 10, 24 Months
Manufacturing Site:
Federal B Area,
Remel house, Clipper boulevard
Karachi. Brucella melitensis
west,crossways,Dartford
Establishment Agglutinating Serum
kent,DA26PT,United Kingdom.
License: R30164901
FSC:
ELI- 00239 Country of Origin 24 Months
Date of R&I United Kingdom
24 -Nov-2022 Validity: 28-03-2027
LOA
Validity:31-12-2025
ISO 13485
Validity: 10-12-2025
75. Legal Manufacturer: M/S IMMY,Inc Approved. Firm
Sona Aspergillus
. submitted FSC of
Musaji Adam & Galactomannan LateralFlow Assay
Manufacturing Site: UK.
Sons (A/C to COE)
IMMY, Inc Product code: AF2003
Address:C-285, 2701 Corporate Centre
Block 10, Class: B
Drive, Norman, Ok Shelf Life: 18 month
Federal B Area,
73069 USA Cluster: Fungal Infection Immunology
Karachi.
CFG & COE: CrAg Lateral Flow
Establishment
Country of Origin: Assay(A/c to CFG)
License:
United States Of Product code: CR2003
ELI-00239.
America Class: B
Shelf Life: 18 month
Validity: 25-06-2025 Size: 50 Tests
LOA Cluster: Fungal Infection Immunology
Date of R&I Validity:31-12-2025 Sona Cube Reader (A/c to CFG)
29-jan-2021
Product code: LFARDR
Class: B
ISO 13485 Shelf Life: 18 month
Validity: 19-09-2027 Cluster: Fungal Infection
Immunology
76. M/s. Glo-Med Legal Manufacturer: HugeMed Video Approved, subject to
Technologies Shenzhen HugeMed Laryngoscope System (Video provisions of valid
Address: A- Medical Technical Laryngoscope) LoA.
21/2 B1, Development Co., Ltd
KDA Scheme
Address: 416-1,516-1, Class A
1 (Ext.),
Building 2, No. 1, Mawu Shelf Life: N/A
National
Stadium Road, Baoan Community,
Road, Yuanshan Street,Longgang Codes/Sizes:
District, Shenzhen 518115, China
Karachi,
Componen Model
Pakistan.
FSC: t Name
Country of Origin: China Validity: Video VL4R
22-10-2025 Laryngosc
ELI-00712
LOA Ope VL4D
Validity: 31-03-2025 Video
R&I details
ISO 13485 Laryngosco
18-04-2023 pe

Decisions of 85th Meeting of MDB (21-03-2025) Page 27 of 138

 Validity: 21-12-2025. Video VL3S
Laryngosco
pe
Video VLRM
Laryngosc
Video ope VLDM
Laryngosco
pe
Single use MAC1,
Laryngosco MAC2,
pe MAC3,
Blade MAC3
1,
MAC4,
MAC5,
MILLE
R00,
MILLE
R0,
CMAC
3,
CMAC
4,
CMAC
5
77. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone Manual
Room # 4 Jason Changhongling Wheelchair
Centre BC-8, Industrial Park
Block Clifton, (2nd Phase), Shishan CLASS: A
Karachi Nanhai District SHELF LIFE:
Pakistan. Foshan CHINA. 05-YEARS

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
78. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone WALKER
Room # 4 Jason Changhongling
Centre BC-8, Industrial Park CLASS: A
Block Clifton, (2nd Phase), Shishan SHELF LIFE: 03
Karachi Nanhai District YEARS
Pakistan. Foshan CHINA.

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.

Decisions of 85th Meeting of MDB (21-03-2025) Page 28 of 138

79. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone CHAIR RAISED
Room # 4 Jason Changhongling TOILET SEAT
Centre BC-8, Industrial Park
Block Clifton, (2nd Phase), Shishan CLASS: A
Karachi Nanhai District SHELF LIFE: 03
Pakistan. Foshan CHINA. YEARS

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
80. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone SHOWER CHAIR
Room # 4 Jason Changhongling
Centre BC-8, Industrial Park CLASS: A
Block Clifton, (2nd Phase), Shishan SHELF LIFE: 03
Karachi Nanhai District YEARS
Pakistan. Foshan CHINA.

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
81. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone ROLLATOR
Room # 4 Jason Changhongling
Centre BC-8, Industrial Park CLASS: A
Block Clifton, (2nd Phase), Shishan SHELF LIFE: 05
Karachi Nanhai District YEARS
Pakistan. Foshan CHINA.

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
82. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone CRUTCH
Room # 4 Jason Changhongling
Centre BC-8, Industrial Park CLASS: A
Block Clifton, (2nd Phase), Shishan SHELF LIFE:
Karachi Nanhai District 03-YEARS
Pakistan. Foshan CHINA.

ELI-00627 FSC VALIDITY:

29-05-2026

Decisions of 85th Meeting of MDB (21-03-2025) Page 29 of 138

 R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
83. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone WALKING
Room # 4 Jason Changhongling STICK
Centre BC-8, Industrial Park
Block Clifton, (2nd Phase), Shishan CLASS: A
Karachi Nanhai District SHELF LIFE: 03
Pakistan. Foshan CHINA. YEARS

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
84. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone ELECTRIC
Room # 4 Jason Changhongling WHEELCHAIR
Centre BC-8, Industrial Park
Block Clifton, (2nd Phase), Shishan CLASS: A
Karachi Nanhai District SHELF LIFE: 05
Pakistan. Foshan CHINA. YEARS

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
85. M/s. Hakimi M/s. Guangdong Dayang Medical (MEDICAL Approved.
Medtech Address: Technology Co., Ltd. BAZAR)
Address: Xingxian Development Zone ELECTRIC
Room # 4 Jason Changhongling HOSPITAL BED
Centre BC-8, Industrial Park
Block Clifton, (2nd Phase), Shishan CLASS: A
Karachi Nanhai District SHELF LIFE: 05
Pakistan. Foshan CHINA. YEARS

ELI-00627 FSC VALIDITY:

29-05-2026
R&I: LOA VALIDITY:
04/09/2024 05-07-2029.
ISO 13485
Validity: 24-06-2025.
86. MOODY Etiometry Inc., Etiometry Platform software Deferred;
Global for clarification
Services Address: 280 Summer Street, Generic Name; regarding the IQ,
Fourth Clinical Decision Support Software OQ and PQ of the
Office address: Floor Boston, MA, USA product at the
Office No. 14, Class A premises of
2nd Floor, Installation.

Decisions of 85th Meeting of MDB (21-03-2025) Page 30 of 138

 Mujahid Plaza, FSC: UK Shelf Life: NA. Further submission
Blue area, Validity: 28-02-2028 Stability studies do not apply to required that in
Islamabad software because software does not which category of
LOA Validity: degrade over time like physical medical equipment
Licence No. 30-06-2029 products. it will be devises
ELI- and what is the
00926 ISO 13485 Model name and its version: (As critical
Date of issue: Validity: 28-02-2027. per FSC) classification of
17-05-2022 T3 Platform Software: DAV5.4 the product use. Its
RAE 10.0 monitoring the
vitals of patient
individually or
whether alongwith
other Software/
medical devices.
87. Cardiac Care VYGON SINGLE valve Approved, subject to
848-C Shadman Address: 5 rue Adeline - 95440 For thoracic provision of original
-1, Lahore. Ecouen – FRANCE Drainage. fee slip, because
annexed slip is not
ELI-00070 FSC issued date: (Pleural drainage valve) legible.
24/07/2023
R&I 25-02- Class A
2021 LOA valid: 31/12/2026.
Fee Challan No ISO 13485 Shelf Life:
2039280 Validity: 09-05-2027. 05-years
dated
22-02-21 CODE: 669.10

88. M/s. Glo-Med Legal Manufacturer: HugeMed Video Approved, subject to

Technologies Shenzhen HugeMed Laryngoscope System (Video provisions of valid
Address: A- Medical Technical Laryngoscope) LoA and differentia;l
21/2 B1, Development Co., Ltd fee of Class-B.
KDA Scheme
Address: 416-1,516-1, Class A
1 (Ext.),
Building 2, No. 1, Mawu Shelf Life: N/A
National
Stadium Road, Baoan Community,
Road, Yuanshan Street,Longgang Codes/Sizes:
District, Shenzhen 518115, China
Karachi,
Componen Model
Pakistan.
FSC: t Name
Country of Origin: China Validity: Video VL4R
22-10-2025 Laryngosc
ELI-00712
LOA Ope VL4D
Validity: 31-03-2025 Video
R&I details
ISO 13485 Laryngosco
18-04-2023 pe
Validity: 21-12-2025.
Video VL3S
Laryngosco
pe
Video VLRM
Laryngosc
Video ope VLDM
Laryngosco

Decisions of 85th Meeting of MDB (21-03-2025) Page 31 of 138

 pe

Single use MAC1,

Laryngosco MAC2,
pe MAC3,
Blade MAC3
1,
MAC4,
MAC5,
MILLE
R00,
MILLE
R0,
CMAC
3,
CMAC
4,
CMAC
5
89. MOODY Etiometry Inc., Etiometry Platform software Deferred;
Global for clarification
Services Address: 280 Summer Street, Generic Name; regarding the IQ, OQ
Fourth Clinical Decision Support Software and PQ of the product
Office address: Floor Boston, MA, USA at the premises of
Office No. 14, Class A Installation. Further
2nd Floor, submission required
Mujahid Plaza, FSC: UK Shelf Life: NA. that in which category
Blue area, Validity: 28-02-2028 Stability studies do not apply to of medical equipment it
Islamabad software because software does not will be devises and
LOA Validity: degrade over time like physical what is the critical
Licence No. 30-06-2029 products. classification of the
ELI- product use. Its
00926 ISO 13485 Model name and its version: (As monitoring the vitals of
Date of issue: Validity: 28-02-2027. per FSC) patient individually or
17-05-2022 T3 Platform Software: DAV5.4 whether alongwith
RAE 10.0 other Software/
medical devices.
90. Name of Firm Legal Manufacture Name of Medical Device Approved;
(s) Manufacturing Site subject to provisions
Thermo Fisher Scientific Oy, of differential fee of
Briogene Pvt Ratastie 2,FI-01620 Vantaa, Finland Clinical Chemistry class-B and brand
Ltd, LOA (Immunochemistry) name.
Expiry Date: 27th January 2026
196-A, Sindhi Class A
Muslim FSC Country of Origin: Finland
Cooperative Date of Issuance: 12-Sep-2024 Shelf Life:
Housing
Society, FSC Reference Country: Australia Codes:
Shahrah-e- Date of Issuance: 27-Feb-2023
Faisal, ISO 13485 Nam Cod She
Karachi Expiry: 31-3-2027 e e lf
Lif
(ELI-00015) e
Hea 9816 18
Date of moly 59 Mo
submission: 7th zing nth
Jan 2025 Reag s
ent

Decisions of 85th Meeting of MDB (21-03-2025) Page 32 of 138

 Fee submitted:
PKR 6,000/-
Challan #
15947038279
Tracking id:
UYW-LPY-
UPLA
91. Name of Firm Legal Manufacture Name of Medical Device Approved subject to
(s) Manufacturing Site Brand name
Thermo Fisher Scientific Oy,
Briogene Pvt Ratastie 2,FI-01620 Vantaa, Finland Clinical Chemistry
Ltd, LOA (Electrolyte Electrodes)
Expiry Date: 27th January 2026
196-A, Sindhi Class B
Muslim FSC Country of Origin: Finland
Cooperative Date of Issuance: 12-Sep-2024 Shelf Life:
Housing
Society, FSC Reference Country: Australia Codes:
Shahrah-e- Date of Issuance: 27-Feb-2023
Faisal, Name C Shelf
Karachi ISO 13485 o Life
Expiry: 31-3-2027 d
(ELI-00015) e
Potass 9 18
Date of ium 8 Mont
submission: 7th (k+) 1 hs
Jan 2025 Micro 5
Volu 9
Fee submitted: me 3
PKR 31,000/- Electr
Challan # ode
34719978117 Chlori 9 Mont
Tracking id: de 8 hs
95P-5N4-G1M8 (Cl-) 1
Micro 5
Volu 9
me 6
Electr
ode
Sodiu 9 Mont
m 8 hs
(NA+ 1
) 5
Micro 9
Volu 4
me
Electr
ode
92. Name of Firm Legal Manufacture Approved, subject to
(s) Manufacturing Site ODAK OBG Forward group provisions of
ISLAB Biyoteknoloji differential fee of
Briogene Pvt Class B class-D.
Ltd, Tibbi Malzeme Saglik Hizmetleri
Sanayi ve Ticaret Anonim Sirketi. Shelf Life:
196-A, Sindhi Kaynarca Mh. Kadirli Sk No:10b/D
Muslim Blok Pendik Codes:
Cooperative Turkey
Housing Name Co Shel
Society, LOA de f

Decisions of 85th Meeting of MDB (21-03-2025) Page 33 of 138

 Shahrah-e- Expiry Date: 13th August 2026 Life
Faisal, ODA O 13
Karachi FSC Country of Origin: Turkey K B Mon
Validity: 22-Dec-2026 OBG G ths
(ELI-00015) Forw F
EC Certificates ard G
Date of FQA group 1-
submission: 4th Validity: 26-May-2025 1 50
February 2025 Design Examination ODA O 13
Validity: 26-May-2025 K B Mon
Fee submitted: OBG G ths
PKR 31,000/- ISO 13485 Forw F
Challan # Expiry: 8-7-2025 ard G
4118038628 group 2-
Tracking id: 2 50
4EX-XW8-
6YBW
93. Name of Firm Legal Manufacture Approved, subject to
(s) ODAK OBG Forward & Reverse provisions of
Manufacturing Site group differential fee of
Briogene Pvt ISLAB Biyoteknoloji class-D.
Ltd, Class B
Tibbi Malzeme Saglik Hizmetleri
196-A, Sindhi Sanayi ve Ticaret Anonim Sirketi. Shelf Life: 13 Months
Muslim Kaynarca Mh. Kadirli Sk No:10b/D
Cooperative Blok Pendik Codes: OBGFRG-50
Housing Turkey
Society,
Shahrah-e- LOA Expiry Date: 13th August 2026
Faisal, FSC Country of Origin: Turkey
Karachi Validity: 22-Dec-2026
EC Certificates
(ELI-00015) FQA
Validity: 26-May-2025
Date of Design Examination
submission: 4th Validity: 26-May-2025
February 2025
ISO 13485
Fee submitted: Expiry: 8-7-2025
PKR 31,000/-
Challan #
793088193072
Tracking id:
Y7N-TV8-
YPAH

94. V care Legal Manufacturer: Stethoscope Approved firm will

International M/S HONSUN (NANTONG) CO provide notarized
8C ,6 sunset LTD.NO 08 TONGXING ROAD Class-A copy of ISO 13485;
commercial NANTONG ECONOMIC AND Shelf life: Firm will provide
Lane Phase 2 TECHNOLOGICAL ST-71 Stethoscope Combined with separate fee for ST-
Extension DEVELOPMENT AREA, AG1-20 (Anerioed BP) 77 Sprague
Defense NANTONG CITY P.R.China Rappaport
housing Distributor: ST-77 Sprague Rappaport Stethoscope
authority Microlife AG Stethoscope
Karachi
ELI: 00433 LOA:
607-C-C 31.12.25

Decisions of 85th Meeting of MDB (21-03-2025) Page 34 of 138

 00210982654 FSC Chins
5000 11-07-2025
R&I 05-10-
2022 ISO 13485
08.03.26
95. V care Legal Manufacturer: Blood Pressure Monitor Approved firm will
International M/S HONSUN (NANTONG) CO Class-A provide notarized
8C ,6 sunset LTD.NO 08 TONGXING ROAD Shelf life: copy of ISO 13485;
commercial NANTONG ECONOMIC AND AG1-20 Aneroid Blood Pressure & valid FSC
Lane Phase 2 TECHNOLOGICAL meter
Extension DEVELOPMENT AREA, AG1-40 Aneroid Blood Pressure
Defense NANTONG CITY P.R.China meter
housing Distributor:
authority Microlife AG
Karachi
ELI: 00433 LOA:
607-C-C 31.12.25

84938557723 FSC Chins

25000 08-12-2024
R&I 05-10-
2022 ISO 13485
08.03.26
96. V care Legal Manufacturer: Compressor Nebulizer NEB210 Deferred firm will
International M/s Shen Zhen Bi rich medical provide valid FSC
8C ,6 sunset devices company LTD BR-CN188 Nebulizer and CE certificate,
commercial The 1st Building of no 10 Xinqiao Class-B LOA from
Lane Phase 2 Gagzai Road, Shelf life: Shenzhen in name
Extension Xinqiao Street Bao.An District, Nebulizer + optional with the of MIcrolife AG also
Defense SHenzen City following three required
housing Distributor: accessory packages:
authority Microlife AG 1.. NEB-210 including adjustable
Karachi Switzerland cup, PVC
ELI: 00433 LOA: tube, nose piece,
607-C-C 31.12.25 2. mouthpiece, adult and child mask;
3. Kids including adjustable cup
78351880937 FSC Chins PVC
25000 paid 14-06-2024 Tube nosepiece adult mask child
17.4.22 mask.
R&I 05-10- ISO 13485
2022 14.07.26 KM-002nebulizer cup PVC tube

97. BIOSORIN ESCO Medical Technologies UAB, Multi-zone ART Workstations Approved subject to
(PRIVATE) Lithuania (MAW) submission of paid
LIMITED 19- Address: Draugystes g. 19, Kaunas, MAW 3D; MAW 4D; MAW 6D fee proof
Usman Block, Lithuania
Main Tel.: +370 686 79269
Boulevard Web: esco-medical.com
New Garden
Town Lahore- LOA:
Pakistan Date of issue 09.1.23
Phone No:
+92-42- FSC Lithunaia
35940533 08-12-2032
+92-42-
35940534 ISO 13485
Fax No: +92- 01.09.25
42-35940535
E-Mail:

Decisions of 85th Meeting of MDB (21-03-2025) Page 35 of 138

 info@biosorin.
com
Web:
https://www.bi
o-sorin.com/

78351880937
25000 paid
17.4.22
R&I
10-06-2024
98. Applicant: (Legal Manufacturer) Pneumatic tourniquet Approved subject to
M/s KASBN Name: M/S. VBM medizintech Digital tourniquet submission of fee as
INTERNATIO Gmbh, Resuscitator bag per S.R.O 1324 for 3
NAL . products as
Company Class: B mentioned in FSC
Address: 41-K, FSC Validity:
Gulberg-III, Country of Origin:
Lahore 54660 - Germany
Pakistan DOI: 05.03.2021
Site Address:
(ELI-00434) ISO 13485
Track ID: 18.02.25
LXB-VTX-
QLDH LOA:
Fee: 5000- Date of issue 31.12.26
Slip:
35907398273
Dated: 24.oct
.22
R&I 19.12.24
99. M/s. Allmed Legal KARL STORZ Fiberscopes and Approved subject to
Solutions Manufacturer: Semiflexible Endoscopes justification as per
Address: KARL STORZ (Fiberscopes with and without MDB how different
A-21/3, KDA SE & CO. KG channel, microscopes used for
Scheme No.1 Germany Semiflexible Endoscopes with and different purpose are
(ext) Address: Dr.- without clubbed as a single
Stadium Road, Karl-StorzStraBe 34 78532 channel)) application or
Karachi Tuttlingen, Class B separate fee for each
ELI-00029 Germany Shelf Life: N/A microscope as
R&I Details: LOA Codes / Sizes : mentioned in FSC of
Date: Validity: country of origin as
07/10/2022 31/12/2025 1. 1001BN1 Broncho- per S. R. O 1324
Slip no. Fiberscope 5.0 x 54
19642727178 FSC: 2. 11001RD1 Rhino-
Rs. 25,000/- Country of Laryngo-Fiberscope 3.7 x
Origin 34
Validity: Not 3. 3 11001UD1 Rhino-
mentioned,
Pharyngo-Laryngo-
issued in Oct.
Fiberscope 5.2x2
2022
4. 11002BD1 Broncho-
FSC: Fiberscope 3.7 x 54
FSC of
Reference 5. 11003BC3 Broncho-
Country US Fiberscope 2.8 x 54
Validity22.05.24
OR
EC Certificate

Decisions of 85th Meeting of MDB (21-03-2025) Page 36 of 138

 Validity: 17-12- 6. 11004BC1 Broncho-
2025 Fiberscope 6.4 x 54
ISO 13485
Validity: 31-05- 7. 11009BC1 Broncho-
2025 Fiberscope 5.6 x 54

8. 11101RP2 Rhino-
Laryngo-Fiberscope 3.5
mm, 30 cm

9. 11101SK2 Rhino-
Laryngo-Fiberscope, 2.5 x
270 mm

10. 11101SP2 Rhino-

Laryngo-Fiberscope, 2.5 x
370 mm

11. 11264BB1 Hystero-

Fiberscope 3.5 mm x 24
cm

12. 11272C1 Cysto-Urethro-

Fiberscope

13. 11272CIU1 Cysto-

Urethro-Fiberscope, PDD
14. 11272CU1 Cysto-Urethro-
Fiberscope

15. 11274AA1 Uretero-

Fiberscope

16. 11278A1 Uretero-Reno-

Fiberscope FLEX-X2S

17. 11278AC1 Ped. Cysto-

Urethro-Fiberscope,
FLEX-X

18. 11278ACU1 Ped. Cysto-

Urethro-Fiberscope,
FLEX-X

19. 11278AI1 Uretero-

Fiberscope, FLEX-X²

20. 11278AU1 Uretero-Reno-

Fiberscope FLEX-X2S

21. 11292AD1 Choledocho-

Fiberscope, 7.5 Fr.

Decisions of 85th Meeting of MDB (21-03-2025) Page 37 of 138

 22. 11292BD1 Choledocho-
Fiberscope, 11 Fr.

23. 11292DE1 Choledocho-

Fiberscope, 15.5 Fr.

24. 11301AA1 Intubation

Fiberscope 2.8 x 65

25. 11301BN1 Intubation

Fiberscope 5.2 x 65

26. 11302BD2 Intubation

Fiberscope 3.7 x 65

27. 11506AA Miniature

Straight Forward
Telescope 0°

28.
29. 29 11508AA Miniature
Straight Forward
Telescope 0°

30. 30 11510A Miniature

Straight Forward
Telescope 0°

31. 31 11510AA Miniature

Straight Forward
Telescope 0°

32. 32 11540AA Mini Straight

Forward Telescope
0°,1.3mm

33. 33 11572A Mini Straight

Forw. Telescope 0°, 0.8
mm

34. 34 11573A Mini Straight

Forward Telescope
0°,1.1mm

35. 35 11574A Mini Straight

Forward Telescope
0°,1.6mm

36. 36 11575A Mini Straight

Forward Telescope
0°,1.3mm

37. 37 11576A Mini Straight

Forward Scope 0°,0.75mm

Decisions of 85th Meeting of MDB (21-03-2025) Page 38 of 138

 38. 38 11577A Mini Straight
Forward Telescope 0°, 1
mm

39. 39 11581A Miniature

Straight Forward
Telescope 0°

40. 40 11582A Miniature

Straight Forward
Telescope 0°

41. 41 11630AA Mini

Straight-Forward
Telescope 0°,2 mm

42. 42 27000K Ureteroscope, 7

Fr., 6°, 34 cm

43. 43 27000L Uretero-

Renoscope, 7 Fr., 6°, 43
cm

44. 44 27001GG Instrument

Port, large

45. 45 27001K Ureteroscope, 8

Fr., 6°, 34 cm

46. 46 27001L Uretero-

Renoscope, 8 Fr., 6°, 43
cm

47. 47 27002K Ureteroscope,

9.5 Fr., 6°, 34 cm

48. 48 27002KP Pediatric

Uretero-Renoscope 7.3 Fr.

49. 49 27002L Uretero-

Renoscope, 9.5 Fr., 6°, 43
cm

50. 50 27003L MICHEL

Uretero-Renoscope, 9.5
Fr.,43cm

51. 51 27010K Ureteroscope, 7

Fr., 34 cm

52. 52 27010L Uretero-

Renoscope, 7 Fr., 43cm

Decisions of 85th Meeting of MDB (21-03-2025) Page 39 of 138

 53. 53 27011K Ureteroscope, 8
Fr., 6°, 34cm

54. 54 27011KA Ureteroscope,

8 Fr., 6°, 34cm

55. 55 27011L Uretero-

Renoscope, 8 Fr., 6°, 43cm

56. 56 27013L GAUTIER

Uretero-Renoscope, 8 Fr.,
41 cm

57. 57 27035BA Universal-

Cysto-Urethroscope, 17 Fr.

100. M/s. Allmed Legal KARL STORZ Hopkins Telescopes Approved subject to
Solutions Manufacturer: (Endoscopes with channel and justification as per
Address: KARL STORZ without MDB how different
A-21/3, KDA SE & CO. KG channel with accessories) microscopes with
Scheme No.1 Germany different names used
(ext) Address: Dr.- Class B for different purpose
Stadium Road, Karl-StorzStraBe 34 78532 Shelf Life: N/A are clubbed in a
Karachi Tuttlingen, Codes / Sizes : single application or
ELI-00029 Germany separate fee for each
R&I Details: LOA 1 26252BC microscope as
Date: Validity: BETTOCCHI®B.I.O.H.® Compact mentioned in FSC of
22/04/2021 31/12/2025 Hysteroscope country of origin as
Slip no. 2 26034AAV HOPKINS® per S. R. O 1324
1964791 FSC: Telescope 0°, 10mm, 23cm
Rs. 25,000/- Country of 3 26034AA HOPKINS® Telescope
Origin 0°, 10mm, 27cm
Validity: Not 4 26038AA HOPKINS® Telescope
mentioned, 0°, 10mm, 27cm
issued in 5 26092AMA HOPKINS®
27/01/2020 Telescope 6°
6 26208AMA HOPKINS®
EC Certificate Telescope 6°
Validity: 17-12- 7 27092AMA HOPKINS®
2025 Telescope 6°
ISO 13485 8 27093AA HOPKINS® Telescope
Validity: 31-05- 6°
2025 9 27292AMA HOPKINS®
Telescope 6°
10 27293AA HOPKINS®
Telescope 6°
11 26075AA HOPKINS®
Telescope 6°, 11mm, 27.5cm
12 27294AA HOPKINS®
Telescope 6°, 18 Fr.
13 27295AA HOPKINS®
Telescope 6°, 18 Fr.
14 27840KA Nephroscope for MIP
L
15 26053CD Telescope Bridge
16 27035BA Universal-Cysto-
Urethroscope, 17 Fr.

Decisions of 85th Meeting of MDB (21-03-2025) Page 40 of 138

 17 27035BB Universal-Cysto-
Urethroscope, 20 Fr.
18 26252BB B.I.O.H.® Compact
Hysteroscope, only
19 7232BA DCI HOPKINS®
Telescope 30°, 4mm, 18cm
20 10970BA DCI® HOPKINS®
Telescope 30°
21 10972BA DCI® HOPKINS®
Telescope 30°, 4 mm/16 cm
22 10972BWA DCI® HOPKINS®
Telescope 30°, 4 mm/16 cm
23 28731AE ENDOCAMELEON®
ARTHRO HOPKINS® Telescope
24 7230AE ENDOCAMELEON®
ENT HOPKINS® Telescope
25 26003AE ENDOCAMELEON®
HOPKINS® Telescope
26 26003AEE
ENDOCAMELEON® HOPKINS®
Telescope
27 26003AS ENDOCAMELEON®
HOPKINS® Telescope
28 26003ASE
ENDOCAMELEON® HOPKINS®
Telescope
29 26003EC ENDOCAMELEON®
HOPKINS® Telescope
30 49003AE ENDOCAMELEON®
HOPKINS® Telescope
31 27005BGA Greenlight
HOPKINS® Telescope 30°, 4 mm
32 26003ARA HOPKINS RUBINA
0°, NIR/ICG, Ø 10 mm
33 26046ARA HOPKINS RUBINA
0°, NIR/ICG, Ø 5 mm
34 26003BRA HOPKINS RUBINA
30°, NIR/ICG, Ø 10 mm
35 26046BRA HOPKINS RUBINA
30°, NIR/ICG, Ø 5 mm
36 26003FRA HOPKINS RUBINA
45°, NIR/ICG, Ø 10 mm
37 26003FREA HOPKINS
RUBINA 45°, NIR/ICG, Ø 10 mm
38 26046FRA HOPKINS RUBINA
45°, NIR/ICG, Ø 5 mm
39 26120AA HOPKINS Telescope
0°, 2.9 mm, 30 cm
40 26004AA HOPKINS Telescope
0°, 3 mm, 14 cm
41 26004BA HOPKINS Telescope
30°, 3 mm, 14 cm
42 26003FCA HOPKINS Telescope
45°, NIR/ICG, Ø 10 mm
43 26003FCEA HOPKINS
Telescope 45°, NIR/ICG, Ø 10 mm
44 26046FCA HOPKINS Telescope
45°, NIR/ICG, Ø 5 mm
45 28305BA HOPKINS® Forward-

Decisions of 85th Meeting of MDB (21-03-2025) Page 41 of 138

 Oblique Telescope 30°
46 27301AA HOPKINS®
Telescope 0°, 1.9 mm
47 58705AA HOPKINS®
Telescope 0°, 1.9 mm, 6.5 cm
48 27017AA HOPKINS®
Telescope 0°, 1.9/2.1 mm
49 10017AA HOPKINS®
Telescope 0°, 1.9/2.1mm
50 7217AA HOPKINS® Telescope
0°, 1.9/2.1mm
51 26003AA HOPKINS®
Telescope 0°, 10 mm, 31 cm
52 50250AA HOPKINS®
Telescope 0°, 10 mm, 31 cm
53 26003AEA HOPKINS®
Telescope 0°, 10 mm, 42 cm
54 8711AA HOPKINS® Telescope
0°, 10mm, 20cm
55 26008AA HOPKINS®
Telescope 0°, 2 mm, 26 cm
56 7207AA HOPKINS® Telescope
0°, 2.7 mm, 11 cm
57 10018AA HOPKINS®
Telescope 0°, 2.7 mm, 18 cm
58 7229AA HOPKINS® Telescope
0°, 2.7 mm, 18 cm
59 27018AA HOPKINS®
Telescope 0°, 2.7mm
60 10023ABA HOPKINS®
Telescope 0°, 2.8 mm, 44 cm
61 27023ABA HOPKINS®
Telescope 0°, 2.8mm
62 10020ATA HOPKINS®
Telescope 0°, 2.9 mm, 30 cm
63 10324AA HOPKINS®
Telescope 0°, 2.9 mm, 36 cm
64 27324AA HOPKINS®
Telescope 0°, 2.9 mm, 36 cm
65 27020AA HOPKINS®
Telescope 0°, 2.9mm
66 7220AA HOPKINS® Telescope
0°, 3 mm, 14 cm
67 26007AA HOPKINS®
Telescope 0°, 3.3 mm, 25 cm
68 7228AA HOPKINS® Telescope
0°, 4 mm, 15 cm
69 28731AWA HOPKINS®
Telescope 0°, 4 mm, 18 cm
70 7230AA HOPKINS® Telescope
0°, 4 mm, 18 cm
71 7230AWA HOPKINS®
Telescope 0°, 4 mm, 18 cm
72 10005AA HOPKINS®
Telescope 0°, 4 mm, 30 cm
73 26105AA HOPKINS®
Telescope 0°, 4 mm, 30 cm
74 27005AA HOPKINS®
Telescope 0°, 4 mm, 30 cm

Decisions of 85th Meeting of MDB (21-03-2025) Page 42 of 138

 75 10328AA HOPKINS®
Telescope 0°, 4.5mm, 50cm
76 27005AR HOPKINS®
Telescope 0°, 4mm
77 26011AA HOPKINS®
Telescope 0°, 5 mm, 24 cm
78 26046AA HOPKINS®
Telescope 0°, 5 mm, 29 cm
79 10320AA HOPKINS®
Telescope 0°, 5.5 mm, 50 cm
80 26048ASA HOPKINS®
Telescope 0°, 5.5 mm, 50 cm
81 12015AA HOPKINS®
Telescope 0°, 5.5 mm, 53 cm
82 8710AA HOPKINS® Telescope
0°, 5.8mm, 19cm
83 7235AWA HOPKINS®
Telescope 0°, 5mm, 18cm
84 8712AA HOPKINS® Telescope
0°, 5mm, 24cm
85 8713AA HOPKINS® Telescope
0°, 5mm, 29cm
86 8714AA HOPKINS® Telescope
0°, 6.5mm, 35cm
87 26003AGA HOPKINS®
Telescope 0°, NIR/ICG, Ø 10 mm
88 8711AGA HOPKINS®
Telescope 0°, NIR/ICG, Ø 10mm
89 8710AGA HOPKINS®
Telescope 0°, NIR/ICG, Ø 5.8 mm
90 1232AA HOPKINS® Telescope
0°, Ø 1.9 mm, 10 cm
91 49003AA HOPKINS®
Telescope 0°, Ø 10 mm
92 1230AA HOPKINS® Telescope
0°, Ø 2.7 mm, 11 cm
93 1216AA HOPKINS® Telescope
0°, Ø 4 mm, 11 cm
94 49011AA HOPKINS®
Telescope 0°, Ø 5 mm
95 49046AA HOPKINS®
Telescope 0°, Ø 5 mm
96 49031AA HOPKINS®
Telescope 0°, ø 6,5 mm
97 26008FUA HOPKINS®
Telescope 12°, 2 mm, 26 cm
98 26020FA HOPKINS®
Telescope 12°, 2.9 mm, 30 cm
99 27020FA HOPKINS®
Telescope 12°, 2.9mm
100 26105FA HOPKINS®
Telescope 12°, 4 mm, 30 cm
101 27005FA HOPKINS®
Telescope 12°, 4 mm, 30 cm
102 27005EA HOPKINS®
Telescope 120°, 4mm
103 7230EA HOPKINS®
Telescope 120°, 4mm, 18cm
104 8575AV HOPKINS®

Decisions of 85th Meeting of MDB (21-03-2025) Page 43 of 138

 Telescope 15°, 4 mm, 17 cm
105 24941BA HOPKINS®
Telescope 30°
106 26072BA HOPKINS®
Telescope 30°
107 24995BA HOPKINS®
Telescope 30° 4 mm, 28.5 cm
108 58705BA HOPKINS®
Telescope 30°, 1.9 mm, 6.5 cm
109 7217BA HOPKINS®
Telescope 30°, 1.9/2.1mm
110 27301BA HOPKINS®
Telescope 30°, 1.9mm
111 26003BA HOPKINS®
Telescope 30°, 10 mm, 31 cm
112 26003BEA HOPKINS®
Telescope 30°, 10 mm, 42 cm
113 26008BA HOPKINS®
Telescope 30°, 2 mm, 26 cm
114 26008BUA HOPKINS®
Telescope 30°, 2 mm, 26 cm
115 58700BA HOPKINS®
Telescope 30°, 2,4 mm, 10 cm
116 28300BA HOPKINS®
Telescope 30°, 2.4 mm, 10 cm
117 28208BA HOPKINS®
Telescope 30°, 2.7 mm, 11 cm
118 7207BA HOPKINS®
Telescope 30°, 2.7 mm, 11 cm
119 10018BA HOPKINS®
Telescope 30°, 2.7 mm, 18 cm
120 27018BA HOPKINS®
Telescope 30°, 2.7 mm, 18 cm
121 28719BA HOPKINS®
Telescope 30°, 2.7 mm, 18 cm
122 7229BA HOPKINS®
Telescope 30°, 2.7 mm, 18 cm
123 7219BVA HOPKINS®
Telescope 30°, 2.7 mm, 18 cm
124 10020BA HOPKINS®
Telescope 30°, 2.9 mm, 30 cm
125 26120BA HOPKINS®
Telescope 30°, 2.9 mm, 30 cm
126 10324BA HOPKINS®
Telescope 30°, 2.9 mm, 36 cm
127 26120BAL HOPKINS®
Telescope 30°, 2.9 mm, 36 cm
128 27020BA HOPKINS®
Telescope 30°, 2.9mm
129 7209BA HOPKINS®
Telescope 30°, 3 mm, 11 cm
130 7220BA HOPKINS®
Telescope 30°, 3 mm, 14 cm
131 26007BA HOPKINS®
Telescope 30°, 3.3 mm, 25 cm
132 27325BA HOPKINS®
Telescope 30°, 3.5mm
133 7228BA HOPKINS®
Telescope 30°, 4 mm, 15 cm

Decisions of 85th Meeting of MDB (21-03-2025) Page 44 of 138

 134 26009BA HOPKINS®
Telescope 30°, 4 mm, 18 cm
135 28731BWA HOPKINS®
Telescope 30°, 4 mm, 18 cm
136 50230BA HOPKINS®
Telescope 30°, 4 mm, 18 cm
137 7230BA HOPKINS®
Telescope 30°, 4 mm, 18 cm
138 7230BVA HOPKINS®
Telescope 30°, 4 mm, 18 cm
139 7230BWA HOPKINS®
Telescope 30°, 4 mm, 18 cm
140 7230BRA HOPKINS®
Telescope 30°, 4 mm, 18 cm
141 26105BA HOPKINS®
Telescope 30°, 4 mm, 30 cm
142 27005BA HOPKINS®
Telescope 30°, 4 mm, 30 cm
143 24954BA HOPKINS®
Telescope 30°, 4 mm, 9.5 cm
144 10328BA HOPKINS®
Telescope 30°, 4.5mm, 50cm
145 10005BA HOPKINS®
Telescope 30°, 4mm
146 28721BWA HOPKINS®
Telescope 30°, 4mm, 18cm
147 26011BA HOPKINS®
Telescope 30°, 5 mm, 24 cm
148 50251BA HOPKINS®
Telescope 30°, 5 mm, 24 cm
149 26046BA HOPKINS®
Telescope 30°, 5 mm, 29 cm
150 10320BA HOPKINS®
Telescope 30°, 5.5 mm, 50 cm
151 26048BSA HOPKINS®
Telescope 30°, 5.5mm, 50cm
152 8712BA HOPKINS®
Telescope 30°, 5mm, 24cm
153 24941BAL HOPKINS®
Telescope 30°, 5mm, 28cm
154 8713BA HOPKINS®
Telescope 30°, 5mm, 29cm
155 26031BA HOPKINS®
Telescope 30°, 6.5mm, 35cm
156 26003BGA HOPKINS®
Telescope 30°, NIR/ICG, Ø 10 mm
157 1232BA HOPKINS®
Telescope 30°, Ø 1.9 mm, 10 cm
158 49003BA HOPKINS®
Telescope 30°, Ø 10 mm
159 1230BA HOPKINS®
Telescope 30°, Ø 2.7 mm, 11 cm
160 1216BA HOPKINS®
Telescope 30°, Ø 4 mm, 11 cm
161 49011BA HOPKINS®
Telescope 30°, Ø 5 mm
162 49046BA HOPKINS®
Telescope 30°, Ø 5 mm
163 27017BA HOPKINS®

Decisions of 85th Meeting of MDB (21-03-2025) Page 45 of 138

 Telescope 30°,1.9/2.1mm, 18cm
164 26003FA HOPKINS®
Telescope 45°, 10 mm, 31 cm
165 26003FEA HOPKINS®
Telescope 45°, 10 mm, 42 cm
166 7229FA HOPKINS®
Telescope 45°, 2.7 mm, 18 cm
167 7219FLA HOPKINS®
Telescope 45°, 2.7 mm, 18 cm
168 7209FA HOPKINS®
Telescope 45°, 3 mm, 11 cm
169 7220FA HOPKINS®
Telescope 45°, 3 mm, 14 cm
170 7220FVA HOPKINS®
Telescope 45°, 3 mm, 14 cm, up
171 7230FA HOPKINS®
Telescope 45°, 4 mm, 18 cm
172 7230FLA HOPKINS®
Telescope 45°, 4mm, 18cm
173 7230FVA HOPKINS®
Telescope 45°, 4mm, 18cm
174 7230FWA HOPKINS®
Telescope 45°, 4mm, 18cm
175 26046FA HOPKINS®
Telescope 45°, 5 mm, 29 cm
176 49205FA HOPKINS®
Telescope 45°, 5 mm, 29 cm
177 26048FSA HOPKINS®
Telescope 45°, 5.5 mm, 50 cm
178 8713FA HOPKINS®
Telescope 45°, 5mm, 35cm
179 49003FA HOPKINS®
Telescope 45°, Ø 10 mm
180 49046FA HOPKINS®
Telescope 45°, Ø 5 mm
181 7217CA HOPKINS®
Telescope 70°, 1.9/2.1mm
182 7207CA HOPKINS®
Telescope 70°, 2.7 mm, 11 cm
183 7229CA HOPKINS®
Telescope 70°, 2.7 mm, 18 cm
184 7219CVA HOPKINS®
Telescope 70°, 2.7 mm, 18 cm
185 27018CA HOPKINS®
Telescope 70°, 2.7mm, 18cm
186 7220CA HOPKINS®
Telescope 70°, 3 mm, 14 cm
187 7228CA HOPKINS®
Telescope 70°, 4 mm, 15 cm
188 28731CWA HOPKINS®
Telescope 70°, 4 mm, 18 cm
189 7230CA HOPKINS®
Telescope 70°, 4 mm, 18 cm
190 7230CWA HOPKINS®
Telescope 70°, 4 mm, 18 cm
191 10005CA HOPKINS®
Telescope 70°, 4 mm, 30 cm
192 27005CA HOPKINS®
Telescope 70°, 4 mm, 30 cm

Decisions of 85th Meeting of MDB (21-03-2025) Page 46 of 138

 193 7230CVA HOPKINS®
Telescope 70°, 4mm, 18cm
194 7230CRA HOPKINS®
Telescope 70°, 4mm, 18cm
195 8712CA HOPKINS®
Telescope 70°, 5mm, 24cm
196 1232CA HOPKINS®
Telescope 70°, Ø 1.9 mm, 10 cm
197 1230CA HOPKINS®
Telescope 70°, Ø 2.7 mm, 11 cm
198 1216CA HOPKINS®
Telescope 70°, Ø 4 mm, 11 cm
199 7230DA HOPKINS®
Telescope 90°, 4mm, 18cm
200 8700DA HOPKINS®
Telescope 90°, 5.8mm,20cm
201 7230AP PDD HOPKINS®
Telescope 0°, 4 mm, 18 cm
202 27005AIA PDD HOPKINS®
Telescope 0°, 4mm
203 8712AP PDD HOPKINS®
Telescope 0°, 5mm, 24cm
204 27005FIA PDD HOPKINS®
Telescope 12°, 4mm
205 7230BP PDD HOPKINS®
Telescope 30°, 4 mm, 18 cm
206 27005BIA PDD HOPKINS®
Telescope 30°, 4mm
207 8712BP PDD HOPKINS®
Telescope 30°, 5mm, 24cm
208 7230FP PDD HOPKINS®
Telescope 45°, 4mm, 18cm
209 27005CIA PDD HOPKINS®
Telescope 70°, 4mm
210 8712CP PDD HOPKINS®
Telescope 70°, 5mm, 24cm
211 8707DP PDD-Tele-
Laryngoscope 90°
212 8706CA Strobo-Laryngoscope
70°, 17 cm
213 8707DA Tele-Laryngo-
Pharyngoscope 90°, 15 cm
214 8700DKA Tele-Laryngo-
Pharyngoscope, 5.8mm
215 8700CKA Tele-Laryngoscope
70°, 5.8 mm
216 1218AA Tele-Otoscope 0°, Ø 3
mm, 6 cm
217 1218BA Tele-Otoscope 30°, Ø
3 mm, 6 cm
218 1215AA Tele-Otoscope,
Telescope 0°, Ø 4 mm, 6cm
219 1215BA Tele-Otoscope,
Telescope 30°, Ø 4 mm,6cm
220 1218FA Tele-Otoscope,
Telescope 45°, Ø 3 mm,6cm
221 1218CA Tele-Otoscope,
Telescope 70°, Ø 3 mm,6cm
222 49020AA VITOM® 25

Decisions of 85th Meeting of MDB (21-03-2025) Page 47 of 138

 Telescope 0°, AA 25 – 75 cm
223 20916025AGA VITOM® II
NIR/ICG Telescope 0°
224 20916025AIA VITOM® II
PDD Telescope 0°
225 26013VDA VITOM® Scope
90° w. green filter
226 20916025DA VITOM® Tel.
90° w Integ. Illuminator
227 20916025AA VITOM®
Telescope 0° w Integ. Illuminator
228 26003BCA HOPKINS®
Telescope 30°, NIR/ICG, Ø 10 mm
229 26046ACA HOPKINS®
Telescope 0°, ICG, Ø 5 mm
230 26046BCA HOPKINS®
Telescope 30°, ICG, Ø 5 mm
231 7215AA Contact-Micro-
Rhinoscope 0°
232 7215BA Contact-Micro-
Rhinoscope 30°
233 26008BAC CAMPO
TROPHYSCOPE®
234 26120BAC CAMPO
TROPHYscope™
235 50253BA HOPKINS®
Telescope 30°, 10 mm, 31 cm
236 10320DA HOPKINS®
Telescope 90°, 5.5mm, 50cm
237 27294N Adapter
238 10970DS Adaptor
239 30141TA Adaptor for 26034
AAT
240 26075V Adaptor for Instrument
channel
241 26034V Adaptor, for working
channel
242 28126CR Arthroscope Sheath
243 28126R Arthroscope Sheath
244 28129CR Arthroscope Sheath
245 28132CR Arthroscope Sheath
246 28133DS Arthroscope Sheath
247 28136EC Arthroscope Sheath
ENDOCAMELEON®
248 28126B Arthroscope Sheath,
5.5 mm/12 cm
249 26120BHA Examination and
Contact Hysteroscope
250 58706AN High Flow
Arthroscope Sheath, 2,8 mm ø
251 58703BH High Flow
Arthroscope Sheath, 3,2 mm ø
252 28130CR High-Flow
Arthroscope Sheath
253 28130R High-Flow
Arthroscope Sheath
254 28131CR High-Flow
Arthroscope Sheath
255 28131R High-Flow

Decisions of 85th Meeting of MDB (21-03-2025) Page 48 of 138

 Arthroscope Sheath
256 28135CR High-Flow
Arthroscope Sheath
257 28136CR High-Flow
Arthroscope Sheath
258 28136DS High-Flow
Arthroscope Sheath
259 28136S High-Flow Arthroscope
Sheath
260 28229S High-Flow Arthroscope
Sheath
261 28303BS High-Flow
Arthroscope Sheath
262 28303DS High-Flow
Arthroscope Sheath
263 28306BN High-Flow
Arthroscope Sheath
264 58706BN High-Flow
Arthroscope Sheath
265 28229DR High-Flow
Arthroscope Sheath, 6.5/12
266 10337TA Sheath for 10337T
267 12016X Sheath Insert
268 8705CKA Slimline Tele-
Laryngoscope 70°, 4mm/18cm
269 27025F Telescope Bridge
270 27025G Telescope Bridge
271 27025GF Telescope Bridge
272 27025GFA Telescope Bridge
273 27027NL Telescope Bridge
274 27034G Telescope Bridge
275 10338LCI Telescope Bridge
276 26055CD Telescope Bridge
277 26069CD Telescope Bridge
278 27025GA Telescope Bridge
279 27032F Telescope Bridge
280 27033F Telescope Bridge
281 27047F Telescope Bridge
282 27068CD Telescope Bridge
283 10338RK Telescope Bridge
284 10338RL Telescope Bridge
285 10338LCD Telescope Bridge
286 10338R Telescope Bridge
287 30117JA Telescope-Adator
288 10434V Adaptor for catheters,
LUER-lock
289 10434Z Adaptor
290 10924D Adaptor, for respirator
291 10924DL Adaptor for respirator
292 10924E Plug for Ventilation
Attachment
293 10924SP Plug for Suction
294 11014L LUER Port with
Stopcocks
295 11014LU Double LUER Port
296 11900ASE Connecting Hose
297 13991CD Double valve channel
splitter
298 13991CLE Connector, for vent

Decisions of 85th Meeting of MDB (21-03-2025) Page 49 of 138

 connection
299 24950F Telescope Bridge
300 26252BM Monobloc Adapter
301 27040LB Adaptor
302 27040SC Adaptor
303 497HCS Telescope Protective
Sheath for 497 HC
304 1218AL Sheath f.LASER probe
and 1218A/AA
305 1218BL Sheath f.LASER probe
and 1218B/BA
306 10320SP Telescope Guide
Sheath
307 10328SP Telescope Guide
Sheath
308 10338S Guide Piece, short, for
suction catheter
309 10510AA Outer Sheath
310 10970 MEDIAFIT Outer
Sheath, Ø 5 mm, 21 cm
311 11272X Guiding Device
312 11510KA Examination Sheath,
ø 1.3 mm, 2 pcs.
313 11510KD Operating Sheath,
straight, 6.5 Fr.
314 11510KE Operating Sheath,
straight, size 5.6 Fr.
315 11510KI Operating Sheath,
curved, 5.6 Fr.
316 11521S Examniation sheat for
11521 A
317 11522S Examniation sheat for
11522 A
318 11540KA Operating Sheath,
straight, size 8 Fr.
319 11540KB Operating Sheath,
curved, 8 Fr.
320 11540KE Operating Sheath,
curved, size 3.3 mm
321 11576KA Examination Sheath,
ø 1.1 mm, 16 cm
322 11576KF Operating Sheath,
1.1/1.3 mm, 16 cm
323 11576KG Operating Sheath,
1.1/0.8 mm, 16 cm
324 11577KA Examination Sheath,
ø 1.3 mm, 16 cm
325 11577KD Operating Sheath,
1.3/0.8 mm, 16 cm
326 11577KE Operating Sheath,
1.3/1.3 mm, 16 cm
327 11605F Operating Sheath, 9 Fr.
328 11605KC Examination Sheath,
Ø 2.7 mm
329 11630KF Operating Sheath, 9
Fr.
330 11630KH Operating Sheath, 9
Fr.
331 11660A Outer tube

Decisions of 85th Meeting of MDB (21-03-2025) Page 50 of 138

 332 11660C Pusher
333 23178K Outer Sheath with
Needle Holder Insert
334 23400 Outer Sheath, insulated,
43 cm
335 23400AD ROTATIP™ Outer
Sheath, insulated, 36 cm
336 23400UD ROTATIP™ Outer
Sheath, insulated, 36 cm
337 23500CD ROTATIP™ Outer
Sheath, insulated, 50 cm
338 24514S Outer Sheath only
339 24886SOW Sliding Cap
340 24910 Rectoscope Tube, 20
mm, 30 cm
341 24911 Rectoscope Tube, 20
mm, 25 cm
342 24912 Rectoscope Tube, 20
mm, 20 cm
343 24913 Rectoscope Tube, 18
mm, 30 cm
344 24914 Rectoscope Tube, 16
mm, 30 cm
345 24915 Rectoscope Tube, 18
mm, 25 cm
346 24916 Rectoscope Tube, 16
mm, 20 cm
347 24918 Rectoscope Tube, 12
mm, 20 cm
348 24919 Rectoscope Tube, 24
mm, 20 cm
349 24941TK TEO® Operating
Rectoscope Tube, 7.5 cm
350 24942T TEO® Operating
Rectoscope Tube
351 24942TK TEO® Operating
Rectoscope Tube
352 24942TKG TEO® Operating
Rectoscope Tube
353 24942TL TEO® Operating
Rectoscope Tube
354 24995 Rectoscope Tube, Ø 20
mm, 25 cm
355 26008KA Operating Sheath,
10.5 Fr.
356 26152BI BETTOCCHI® Inner
Sheath
357 26152BO BETTOCCHI®
Outer Sheath
358 26152DA Continuous-Flow
Examination Sheath
359 26152DB Continuous-Flow
Operating Sheath
360 26153BI BETTOCCHI® Inner
Sheath
361 26153BIL BETTOCCHI®
Inner Sheath
362 26153BO BETTOCCHI®
Outer Sheath

Decisions of 85th Meeting of MDB (21-03-2025) Page 51 of 138

 363 26153BOL BETTOCCHI®
Outer Sheath
364 26153CI BETTOCCHI® Inner
Sheath
365 26153CO BETTOCCHI®
Outer Sheath
366 26153DB Continuous-Flow
Operating Sheath
367 26153DC Continuous-Flow
Operating Sheath
368 26154BI BETTOCCHI® Inner
Sheath
369 26154BO BETTOCCHI®
Outer Sheath
370 26161CE Examination Sheath,
Ø 4.1 mm
371 26161CF CF Examination
Sheath, Ø 5 mm
372 26161R Continuous-Flow
Outer Sheath, Ø 3.6 mm
373 26161RN Inner Sheath, Ø 2.8
mm
374 26161U Operating Sheath, 9 Fr.
375 26161UF Operating Sheath,
11.5 Fr.
376 26161VB Inner Sheath, Ø 3.8
mm
377 26161VC Outer Sheath, Ø 4.5
mm
378 26161VS Examination Sheath,
ø 4.1 mm
379 26162VB Examination Sheath,
Ø 3.8 mm
380 26163CS CF Operating Sheath,
Ø 7 mm
381 26163HN Operating Sheath
382 26163V Examination Sheath, Ø
5.1 mm
383 26163VB Examination Sheath,
diameter 5.2 mm
384 26163VC Outer Sheath, Ø 6.2
mm
385 26164VB Inner Sheath, Ø 5.2
mm
386 26167KS Handle with Outer
Sheath, size 3 mm
387 26168DE Sheath
388 26168JB Outer Sheath
389 26168JQ Manipulator Sheath
390 26168ZB Manipulator Sheath
391 26176HS Outer Tube
392 26176HSX Outer Tube
393 26177HS Outer Tube
394 26182D Diagnostic Sheath, ø
3.7 mm
395 26182TG Operating Sheath, Ø
6.6 mm
396 26183MB SUPRALOOP Outer
Sheath, 5 mm, 30 cm

Decisions of 85th Meeting of MDB (21-03-2025) Page 52 of 138

 397 26184HS Outer Tube, size 3
mm
398 26184HSS Outer Tube, size 3
mm
399 26188FA Outer Sheath
400 26190AB Outer Tube for 26190
A
401 26193DA Outer Sheath for
26193D
402 26193DB Inner Sheath for
26193D
403 26252BO B.I.O.H. Outer
Sheath, 4 mm
404 26596CAA Outer Tube
405 26596CAI Inner Tube
406 27023RB Sheath for Uretero-
Resectoscope
407 27026A Cystoscope Sheath, 25
Fr.
408 27026AA Cystoscope Sheath,
25 Fr.
409 27026AB Cystoscope Sheath,
25 Fr.
410 27026B Cystoscope Sheath, 22
Fr.
411 27026BA Cystoscope Sheath,
22 Fr.
412 27026BB Cystoscope Sheath,
22 Fr.
413 27026C Cystoscope Sheath, 20
Fr.
414 27026CA Cystoscope Sheath,
20 Fr.
415 27026CB Cystoscope Sheath,
20 Fr.
416 27026CC Cystoscope Sheath,
20 Fr.
417 27026D Cystoscope Sheath, 19
Fr.
418 27026DA Cystoscope Sheath,
19 Fr.
419 27026DB Cystoscope Sheath,
19 Fr.
420 27026U Cystoscope Sheath, 17
Fr.
421 27026UA Cystoscope Sheath,
17 Fr.
422 27026VA Outer Sheath, 23 Fr.
423 27026VI Inner Sheath,with
7.5Fr. working channel
424 27026VIL Inner Sheath
425 27027KL Cystoscope Sheath,
22 Fr.
426 27029CN Cystoscope Sheath, 7
Fr.
427 27029DN Cystoscope Sheath, 9
Fr.
428 27031E Cystoscope Sheath, 9.5
Fr.

Decisions of 85th Meeting of MDB (21-03-2025) Page 53 of 138

 429 27031F Cystoscope Sheath, 11
Fr.
430 27032K Cystoscope Sheath, 11
Fr.
431 27032L Cystoscope Sheath, 13
Fr.
432 27032M Cystoscope Sheath,
14.5 Fr.
433 27033C Cystoscope Sheath, 8
Fr.
434 27033CR Cystoscope Sheath, 8
Fr.
435 27033D Cystoscope Sheath, 9
Fr.
436 27033R Resectoscope Sheath, 9
Fr.
437 27034A Cystoscope Sheath, 14
Fr.
438 27034B Cystoscope Sheath, 16
Fr.
439 27820BA Operating Sheath,
8.5/9.5 Fr.
440 27820BAS Operating Sheath,
for supine position
441 27820BB Operating Sheath,
11/12 Fr.
442 27820BBS Operating Sheath,
for supine position
443 27820BK Operating Sheath for
Children
444 27830BA Operating Sheath,
15/16 Fr.
445 27830BAS Operating Sheath
for Supine Position
446 27830BB Operating Sheath,
16.5/17.5 Fr.
447 27830BBS Operating Sheath
for Supine Position
448 27830BC Operating Sheath,
21/22 Fr.
449 27830BCS Operating Sheath
for Supine Position
450 27830BK Operating Sheath for
Children
451 27840BA Operating Sheath,
23/24 Fr.
452 27840BAS Operating Sheath
for Supine Position
453 27840BB Operating Sheath,
25/26 Fr.
454 27840BBS Operating Sheath
for Supine Position
455 28147BH Arthroscope Sheath
456 28147C OR Sheath,
continuously slotted
457 28179GH Half Pipe, long
458 28179GK Half Pipe, short
459 28728LH Half Pipe®, long
460 28728MH Half Pipe®, small

Decisions of 85th Meeting of MDB (21-03-2025) Page 54 of 138

 461 28728SH Half Pipe®, short
462 50200EK Telescope Sheath,
beak 5 mm
463 50200LS Telescope Sheath f.
50200 L/LM/LL
464 50251LCS Telescope Sheath
for 50251 LC/LD
465 50251MS Sheath
466 58000KA Examination Sheath
1.1 mm
467 58001KA Examination Sheath
1.0 mm
468 224202 Protection Tube, 28 cm
469 225150 Protection Tube, metal,
6 cm
470 553514 Metal Outer Sheath, 3.5
mm, 14 cm
471 555014 Metal Outer Sheath, 5
mm, 14 cm
472 655001 Telescope Sheath, 3.5
mm x 10.5 cm
473 655002 Telescope Sheath, 2.5
mm x 9 cm
474 655003 Telescope sheath, 5 mm
x 16 cm
475 655004 Telescope sheath for
dental surgery
476 655005 Telescope sheath for
dental surgery
477 722010A SCHERER LASER
Rhinoscope Sheath 0°
478 722010B SCHERER LASER
Rhinoscope Sheath, 30°
479 26711547 Sheath oblique 12
mm ø
480 26711557 Sheath oblique 15
mm ø
481 8661P Adaptor for Suction
Tubes 8661M/N
482 10316LR Adaptor, for 10316
AS-DS
483 10337TB Distance Ring for
10337T
484 23004A2 Introducer Sleeve, 13
mm
485 23004A3 Introducer
486 23005ID LUER-Lock
Connector
487 23010AS Attachment
ENDOCONE, for S-PORT® Seal
488 23010SA ENDOCONE® seal
489 23020S Sealing Cap
490 23030E Attachment, S-PORT,
for ENDOCONE® seal
491 23030P Port ring
492 23030S Sealing Cap
493 23030X Attachment, S-PORT,
for X-CONE sealing
494 23040A Adaptor for SAAD

Decisions of 85th Meeting of MDB (21-03-2025) Page 55 of 138

 Retrieval Tube
495 24941I Insertion aid
496 24943S TEO® High-Flow
Adaptor for S-PORT® Seal
497 24944S Sealing Cap for DAPRI
Rectoscope Tube
498 24980A Adaptor
499 26167A Adaptor
500 26182TD Changing Rod, ø 2.9
mm
501 27022Y Insert Cone
502 27026VY LASER Cystoscope
Adaptor
503 27026X NICKELL Cystoscope
Adaptor
504 27050ALC Adaptor
505 27050LC Adaptor
506 27074SC Adaptor
507 27074SZ Adaptor
508 27093GM Adaptor
509 27093GN Adaptor
510 27093SC Adaptor
511 27094BY Adaptor
512 27210A Adaptor for TOOMEY
Syringe
513 27213 Adaptor
514 27506 Catheter Adaptor
515 27507 Catheter Adaptor
516 27550A Sealing Cap, Ø 0.8 mm
517 27550C Sealing Cap, Ø 1.2 mm
518 27550D Sealing Cap, without
drill hole
519 27618 Insertion Mandrin
520 28124BX Changing Rod,
length 23 cm
521 28124BZ Changing Rod
522 28140EWK Changing Rod
ENDOCAMELEON, cannulated
523 28140W Changing Rod, Ø 4.8
mm
524 28140WK Changing Rod,
cannulated, 31 cm
525 28270W Changing Rod, length
35 cm
526 28302W Changing Rod
527 30120Y Spare Silicone Leaflet
Seal, 5x
528 30140DA Reduction Sleeve
529 30140DB Reduction Sleeve,
11/5 mm
530 30140DD Reduction Sleeve
531 30140EB Reduction Sleeve
532 30140EE Reduction Sleeve
533 30140FB Reduction Sleeve
534 30140FE Reduction Sleeve
535 30140GB Reduction Sleeve
536 30140GE Reduction Sleeve
22/10 mm
537 30140HB Reducer 13/5 mm

Decisions of 85th Meeting of MDB (21-03-2025) Page 56 of 138

 538 30140HE Reduction Sleeve
13/10 mm
539 30140K Guide Sleeve
540 30140KA Reduction Sleeve
541 30141AA Reducer
542 30141DB Reducer 11/5mm
543 30141HB Reducer
544 30141HE Reducer, 13/10 mm
545 30141RS Reducer
546 30142HB Double Reducer
547 30142RS Reducer
548 30143RS Reducer
549 58702W Changing Rod
550 230000 Ventilation Drainage
Tube Inserter, 10cm
551 469602 Guard for Forceps
469600/488038
552 27502 LUER-Lock Tube
Connector
553 26208OC Obturator for 26208
AMA
554 8715AA Contact Micro
Laryngoscope 0°
555 8715BA Contact-Micro-
Laryngoscope 30°
556 10030AA Miniature Telescope
0°, semirigid
557 10040AA Mini Straight
Forward Telescope 0°,1.3mm
558 26003ACA HOPKINS®
Telescope 0°, NIR/ICG, Ø 10 mm
559 26604BA HOPKINS Telescope
30°, 3 mm, 14 cm
560 26605AA HOPKINS® Straight
Fwd Telescope 0°
561 26605BA HOPKINS®
Telescope 30°, 8mm, 29cm

101. M/s. Allmed Legal KARL STORZ Pumps Approved subject to

Solutions Manufacturer: (Pumps, Foot Switches for Pumps, justification as per
Address: KARL STORZ Tubing Sets (sterile/non-sterile)) MDB how different
A-21/3, KDA SE & CO. KG Class A microscopes with
Scheme No.1 Germany Shelf Life: N/A different names
(ext) Address: Dr.- Codes / Sizes used for different
Stadium Road, Karl-Storz- StraBe S purpose are clubbed
Karachi 34 78532 # in a single
ELI:00029 Tuttlingen, Article application or
R&I details Germany No. Description separate fee for each
Date: FSC: Germany 1 UP501 S-PILOT microscope as
30/12/2022 Validity: Not 2 030547-01 mentioned in FSC of
Slip no. mentioned, issued Tubing Set, country of origin as
78277421 in Oct. 2022 Suction, EXTRALARGE LL per S. R. O 1324
Rs. 5000 LOA 3 030948-01 Tubing Set,
Validity: Suction, LUER
31/12/2025 4 20300042 Silicone Tubing
Set, suction
5 26331142 Silicone Tubing
Set, suction
6 UP009 Tubing Set,

Decisions of 85th Meeting of MDB (21-03-2025) Page 57 of 138

 suction, DS
7 UP010 Tubing Set,
suction, BS
8 030748-01 Tubing Set,
Suction
9 031124-10 Filter, Suction
10 20300032 Bottle Stand, for
bottle 5 l
11 20300034 Bottle Cap, 1.5 and
5l
12 20300039 Cap for Suction
Bottle 20300051
13 20300050 Suction Bottle, 5 l,
sterilizable
14 20300051 Suction Bottle, 0.5
l
15 20701070 Control Cable
16 27610070 Connecting Cable
17 27610072
Connecting cable,
transducer/
generator
18 UP006 Control Cable
102. M/s. Jasani Legal Manufacturer: Brand name: Approved subject to
Scientifics SC- C.S.O. Srl, SL-9900 Slit Lamp remaining fee and
45, Marium Address: Via degli Generic: provision of Fsc
Square, chandni Stagnacci, 12e, Slit Lamp notorized and
Chowk, 50018 Scandicci Fl Model: countersigned by
Stadium road, Italy. (SL-2000) embassy
Karachi. Class: A
(ELI-00416) FSC Italy issuance date:
Date of R&I 06-11-2017
13/03/2025
Fee: PKR ISO 13485 validity:
5000/- 16-12-2026
Slip:
9741390814 LOA Validity:
31-12-2027
Dated:
03/04/2023

103. M/s Jasani Legal Manufacturer: Brand Name Approved subject to

Scientifics C.S.O. Srl, SIRIUS TOPOGRAPHER remaining fee
SC-45, Marium Address: Via degli (CORNEAL TOPOGRAPHER)
Square, chandni Stagnacci, 12e, Class A
Chowk, 50018 Scandicci Fl Shelf life: N/A
Stadium Italy. GMDN Codes: 18038
road, Karachi, Codes and Sizes as per FSC
74800, FSC Italy issuance date:
ELI-000416 12-11-2014
R&I:
13/03/2025 ISO 13485 validity:
Fee Slip No: 16-12-2026
2040342371
Fee Submission LOA Validity:
Date: 31-12-2027
03/04/2023
104. M/s Jasani Legal Manufacturer: Brand Name Approved subject to
Scientifics C.S.O. Srl, A-900 Applanation Tonometer remaining fee

Decisions of 85th Meeting of MDB (21-03-2025) Page 58 of 138

 SC-45, Marium Address: Via degli (Tonometer)
Square, chandni Stagnacci, 12e, Class A
Chowk, 50018 Scandicci Fl Shelf life: N/A
Stadium Italy. GMDN Codes: 16809
road, Karachi, Codes and Sizes as per FSc
74800, FSC Italy issuance date:
ELI-000416 12-11-2014
R&I:
13/03/2025 ISO 13485 validity:
Fee Slip No: 16-12-2026
23849473549
Fee LOA Validity:
Submission 31-12-2027
Date:
03/04/2023
105. M/s. Unique Legal Manufacturer: BRAND NAME: Firm has applied
Visual System M/s Jilin Realcon FRESHGO same product with 2
L-18, Block-17, Optical Technology Generic Name different brand
Gulshan-e- Co.,Ltd. Realcon Color 38 names. Approved 1
Iqbal, Address: Soft Contact Lens product out of Sr No.
Karachi, No.88, Changchun HS CODE 12-13
Pakistan Street, Yongji 9001.3000
ELI-00449 Economic Class B
Development Zone, Shelf Life: 5 Years
R&I: JilinCity, Jilin, CHINA
14/06/2024 https://www.realconle
Fee Submission ns.com
Date: CE FQAS
10/06/2024 Validity 27 05 2024
25000/-
FSC: CHINA
Validity: Jan 12, 2025
LOA
Validity:
Issued on April 1, 2024
(LOA is valid until
further notice)
ISO 13485
VALIDITY:
November 3, 2027
106. M/s. Unique Legal Manufacturer: BRAND NAME: Firm has applied
Visual System M/s Jilin Realcon MAGISTER same product with 2
L-18, Block-17, Optical Technology Generic Name different brand
Gulshan-e- Co.,Ltd. Realcon Color 38 names. Approved 1
Iqbal, Address: Soft Contact Lens product out of Sr No.
Karachi, No.88, Changchun HS CODE 12-13
Pakistan Street, Yongji 9001.3000
ELI-00449 Economic Class B
Development Zone, Shelf Life: 5 Years
R&I: JilinCity, Jilin, CHINA
14/06/2024 https://www.realconle
Fee Submission ns.com
Date: CE FQAS
10/06/2024 Validity 27 05 2024
25000/-
FSC: CHINA
Validity: Jan 12, 2025
LOA
Validity:

Decisions of 85th Meeting of MDB (21-03-2025) Page 59 of 138

 Issued on April 1, 2024
(LOA is valid until
further notice)
ISO 13485
VALIDITY:
November 3, 2027
107. M/s. LIFE M/s Brand Name; approved
CARES FORTUNE MEDICAL
INSTRUMENT CORP. FORTUNE
M-20
Mezzanine 6F., No.29, Sec.2, Generic Name;
Floor, Jhongjheng E., Rd., AMBU BAG Manual Resuscitator
Falak naz Plaza Danshuei Dist, New Taipei
Main City 251, Taiwan. Class A
Shahra -e-Faisal
Karachi 75200. ShelfLife:5years
Tel: 021- LOA:
34581903 Validity Date: Codes / Sizes
Lifecares@hot 24th January 2026 1610-0001, 1610-002, 1610-0003,
mail.com 1650
0001,
ELI-00077 FSC:(Taiwan) 1650-0002, 1650-0003, 1690-0001,
1690
R&I 22.11.21 Validity: 0002, 1690-0003, 1611-9000, 1611-
26-01-2027 9001,
1611-9002, 1611-9003, 1611-9004,
FSC THE 1611
NETHERLANDS 9005, 1611-9093, 1611-9094, 1611-
9095,
Validity 1651-9000, 1651-9001, 1651-9002,
31-12-2028 1651
9003, 1651-9004, 1651-9005, 1691-
9000,
ISO: 13485 1691-9001, 1691-9002, 1691-9003,
(validity: 1691
08-08-2025 9004, 1691-9005, 1603-9040, 1603-
9050,
EC FQA: 1603-9060, 1603-9070, 1603-9080,
(validity: 1603
31-12-2028 9090, 1603-9100, 1603-0040, 1603-
MDR Confirmation letter 0050,
Attached 1603-0060, 1603-0070, 1603-0080,
1603
0090, 1603-0100, 1603-0110, 1601-
9001,
1601-9002, 1601-9003, 1602-9001,
1602
9060, 1602-9260, 1604-9007, 1605-
8001,
1605-9001, 1606-8010, 1606-8020,
1606
9010, 1606-9020, 1607-9001
108. M/s Pulse Name: Argon Brand name: Approved. Subject to
Surgical Medical Devices, Intara™ The firm will submit
Address: Suite Inc. notorized copies of
No. Address: 1445 Flat Generic name: ISO 13485 & Fsc
113, First floor, Creek road, Athens, Introducer sheath
Almas height, Texas 75751 USA
190/1, Specification/sizes:

Decisions of 85th Meeting of MDB (21-03-2025) Page 60 of 138

 Block 2 ISD10040 Intara™
PECHS, FSC USA validity: Introducer Sheath 10F
Karachi, 75400 15-05-2026 x 41.5cm
Pakistan
Class: B
License No. LOA validity:
ELI-00578 DOI Shelf life:
23-06-2023 3 years
Receipt No.
8536842690 ISO 13485
31000 VALIDITY:
21.1.25 28.4.25

R&I:
21.1.25
109. M/s Pulse Name: Brand name: Approved. Subject to
Surgical TECHNOMED Technomed The firm will submit
Address: Suite EUROPE Generic name: notarized copies of
No. Address: Electromyographic ISO 13485 & Fsc
113, First floor, Amerikalaan 71, Needle Electrode
Almas height, 6199 AE Specification/sizes:
190/1, Maastricht-Airport DISPOSABLE
Block 2 The Netherlands HYPODERMIC
PECHS, NEEEDLE
Karachi, 75400 FSC Netherlands validity: ELECTRODE
Pakistan 05-04-2028 TEL/LXXXX-335
Class: B
License No. LOA validity: Shelf life:
ELI-00578 Dec 2025 3 years

Receipt No. ISO 13485

2105322 VALIDITY:
25000 01.3.26
31.3.21

R&I:
6.4.21
110. M/s Pulse Name: Brand name: Approved
Surgicals TECHNOMED Technomed
Address: Suite EUROPE Generic name:
No. Address: Electromyographic
113, First floor, Amerikalaan 71, Needle Electrode
Almas height, 6199 AE Specification/sizes:
190/1, Maastricht-Airport DISPOSABLE
Block 2 The Netherlands CONECNTRIC
PECHS, NEEEDLE
Karachi, 75400 FSC Netherlands validity: ELECTRODE
Pakistan 05-04-2028 TE/B50035-XXX
License No. Class: B
ELI-00578 LOA validity: Shelf life:
Receipt No. Dec 2025 3 years
2105321
ISO 13485
VALIDITY:
01.3.26
111. M/s importer Legal Manufacturer Name of Medical device Deferred for
A ONE Name: provision of Fsc of
TRADERS SAFE+ ref country or CE|
name with Zhejiang Huafu certificate and

Decisions of 85th Meeting of MDB (21-03-2025) Page 61 of 138

 complete Medical Equipments URINE BAG notorised valid LOA
address as Co. , Ltd. and Fsc and
per Form-4. TYES: ISO13485
Add： (SIMPLES URINE BAG ,
House No.45 , No 688 Xinxing 1st URINE BAG WITH T-VALUE
Street No.4 Road , Pingua City 1000ML, 2000 ML )
Haroon Abad ,Zhejiang Province ,
,Near Malik 314200 China. Class: A
Tariq
Awan Qilla FSC Netherlands validity: Shelf Life : 5 Years
,Ring 05-04-2028
Road Peshawar MD group: SET
, KPK. LOA validity:
9.2.25 LOA Validity: 09/02/2027
(ELI-00480)
ISO 13485 FSC Validity: 21/05/2025
R&I Dated: VALIDITY:
29-07 -2022 03.2.27

112. M/s importer Legal Manufacturer Name of Medical device Deferred for
A ONE Name: provision of Fsc of
TRADERS SAFE+ ref country or CE|
name with Zhejiang Huafu certificate and
complete Medical Equipments HEPARIN CAP (INJECTION notorised valid LOA
address as Co. , Ltd. STOPPER) and Fsc and
per Form-4. ISO13485
Add： TYES:
House No.45 , No 688 Xinxing 1st (YELLOW , TRANSPARENT)
Street No.4 Road , Pingua City
Haroon Abad ,Zhejiang Province , Class: B
,Near Malik 314200 China.
Tariq Shelf Life : 5 Years
Awan Qilla FSC validity:
,Ring 21-04-2021 MD group: SET
Road Peshawar
, KPK. LOA validity:
9.2.25
(ELI-00480)
ISO 13485
R&I Dated: VALIDITY:
15-02 -2022 03.2.27

113. Cardiac Care Ningbo Greetmed Nasal oxygen Deferred for

848-C Medical Instruments Co., Ltd. cannula provision of Fsc of
Shadman -1, Add.: 16F-1, Building 1, No.98 (Oxygen delivery ref country or CE|
Lahore Chuangyuan Road, cannula) certificate and
Hi-Tech Zone, 315042 notorised LOA, brand
ELI-00070 Ningbo, Zhejiang name and Fsc
Province, PEOPLE'S CLASS: B
R&I dated: REPUBLIC OF CHINA
16-01-24 SHELF LIFE: 05
. YEARS.
Challan No CODE
133643723118 FSC VALID: 09-11-2025 XXS,XS,S,M,L
dated 08-01-24 LOA VALID: 09-10-2026
ISO : 31-03-24

Decisions of 85th Meeting of MDB (21-03-2025) Page 62 of 138

114. Cardiac Care Ningbo Greetmed Brand Name Description of Deferred for
848-C Medical Instruments Co., Nebulizer Mask provision of Fsc of
Shadman -1, Ltd. (Medicine ref country or CE|
Lahore Add.: 16F-1, Building 1, administer mask) certificate and
No.98 Chuangyuan Road, notorised LOA and
R&I 16-01- Hi-Tech Zone, 315042 CLASS: B Fsc
2024 Ningbo, Zhejiang
Fee Challan No Province, PEOPLE'S SHELF LIFE: 05
6176555165 REPUBLIC OF CHINA YEARS.
dated Tel: +86-574-87722370
18-12-23 Fax: +86-574-87722360 ISO VALID: 31-03-24
Website:
www.chinagreetmed.com CODE
FSC VALID: 09-11-2025 S,M,L,XL
LOA VALID: 09-10-2026 the device :
ISO : 31-03-24 Nebulizer is used
for atomization
inspiration
treatmen by
oxygen or oil free
compressed air
power source.
Lahore
ELI-00070

115. M/s Quantum, BTL Industries LtD UK Neutral Rejected Application

Suite No. 801, Electrode is not as per SOP
8th Floor, Japan ISO : 08-04-27 BTL-NE-170
Plaza, M. A
Jinnah Road
Karachi.
Godown
Address:Ware
House E-30,
Sector 31/D,
Korangi
Industrial Area
Karachi
116. M/s Quantum, BTL Industries LtD UK Forehead Applicator Rejected Application
Suite No. 801, Cheek Applicator is not as per SOP
8th Floor, Japan ISO : 08-04-27 Submentum Applicator
Plaza, M. A
Jinnah Road
Karachi.
Godown
Address:Ware
House E-30,
Sector 31/D,
Korangi
Industrial Area
Karachi
117. M/s Chemical Legal Manufacturer: Brand: TOX/SEE Drug screen test Approved
House ABON Biopharm (Hangzhou) Co. (194- 5182)
6-C sikandar Ltd. Address: #198, 12 th street east,
Malhi road Hongzhou, economic and (Tox/see drug screen test THC COC
Canal park technological department area, OPI MET MTD AMP BAR BZO
Gulberg-III 310018, Hangzhou, Republic of (25 test))
Lahore. China.
Model: 194-5182

Decisions of 85th Meeting of MDB (21-03-2025) Page 63 of 138

 (ELI-00156) Distributor name: (in USA) Class A
Biorad laboratories Inc.
Date of R&I: Address: 4000 Alfred Nobel drive Shelf Life: 02 years
25/02/2025 Hercules CA, USA 94547.)
Manufacturing Site(s): (ABON
Fee Challan Biopharm (Hangzhou) Co. Ltd.
No.: Address: #198, 12 th street east,
15851259338 Hongzhou, economic and
PKR: 6000/- technological department area,
Dated: 08-01- 310018, Hangzhou, Republic of
2025 China)

118. M/s. Ontech Legal Manufacturer: Brand: Versius Drapes Approved

Corporation P3 Medical Ltd Address: 1 Generic: (Medical Equipment
Address: B-154 Newbridge Close Bristol, BS4 4AX, Drapes for Surgical Robotic
Block 13-D/2 United Kingdom. System)
Gulshan-e- Marketing Authorization Holder: Class A
Iqbal, Karachi. M/s. CMR Surgical Ltd. Address: Device Ref: Shel
Evolution Business Park, Milton Rd, f life
(ELI-00289) Cambridge, CB24 9NG, United Versius
Kingdom Instrum
Date of R&I: ent
31/01/2023 Bedside 12
2010
Unit mon
0
Fee Challan Drape ths
No.: (Standar
012461374105 d) (Qty.
PKR: 5000/- 1)
Dated: 20-01- Versius
2023 Instrum
ent
12
Bedside 2030
mon
Unit 0
ths
Drape
(Long)
(Qty. 1)
Versius
Visualis
ation
Bedside 24
2020
Unit mon
0
Drape ths
(Standar
d) (Qty.
1)
Versius
Visualis
ation
24
Bedside 2040
mon
Unit 0
ths
Drape
(Long)
(Qty. 1)
Versius
Camera 36
2050
Head mon
0
Drape ths
(Qty. 1)

Decisions of 85th Meeting of MDB (21-03-2025) Page 64 of 138

 Versius
Camera
36
Head 2050
mon
Drape 1
ths
(Qty.
25)
Drape
12
Cap 2090
mon
Insert 0
ths
(Qty. 1)
Drape
Cap 12
2090
Insert mon
1
(Qty. ths
100)
Versius
Instrum
ent
Bedside 12
2010
Unit mon
1
Drape ths
(Standar
d) (Qty.
5)
Versius
Instrum
ent
12
Bedside 2030
mon
Unit 1
ths
Drape
(Long)
(Qty. 5)
Versius
Visualis
ation
Bedside 24
2020
Unit mon
1
Drape ths
(Standar
d) (Qty.
10)
Versius
Visualis
ation
Bedside 24
2040
Unit mon
1
Drape ths
(Long)
(Qty.
10)
119. M/s. Ontech Legal Manufacturer: Brand: Versius Drapes Approved
Corporation Richard Wolf GmbH Address: Generic: (Medical Equipment
Address: B-154 Pforzheimer Straße 32, 75438 Drapes for Surgical Robotic
Block 13-D/2 Knittlingen, Germany. System)
Gulshan-e- Marketing Authorization Holder: Class A
Iqbal, Karachi. M/s. CMR Surgical Ltd. Address: Device Ref: Shel
Evolution Business Park, Milton Rd, f life
(ELI-00289) Cambridge, CB24 9NG, United Versius 2010 12
Kingdom

Decisions of 85th Meeting of MDB (21-03-2025) Page 65 of 138

 Date of R&I: Instrum 0 mon
18/09/2023 ent ths
Bedside
Fee Challan Unit
No.: Drape
29480863108 (Standar
PKR: 5000/- d) (Qty.
Dated: 12-09- 1)
2023 Versius
Instrum
ent
12
Bedside 2030
mon
Unit 0
ths
Drape
(Long)
(Qty. 1)
Versius
Visualis
ation
Bedside 24
2020
Unit mon
0
Drape ths
(Standar
d) (Qty.
1)
Versius
Visualis
ation
24
Bedside 2040
mon
Unit 0
ths
Drape
(Long)
(Qty. 1)
Versius
Camera 36
2050
Head mon
0
Drape ths
(Qty. 1)
Versius
Camera
36
Head 2050
mon
Drape 1
ths
(Qty.
25)
Drape
12
Cap 2090
mon
Insert 0
ths
(Qty. 1)
120. M/s. Allmed Legal Manufacturer: Fiber Light Cable & Light Source Approved
Solutions KARL STORZ SE & CO. KG (Fiber Light Cable and Light Source
Address: Germany with Adapters)
A-21/3, KDA Class A
Scheme No.1 Address: Dr.-Karl-Storz- StraBe 34 Shelf Life: N/A
(ext) Stadium 78532 Tuttlingen, Germany Codes / Sizes
Road, Karachi Article Descriptio
FSC: Germany No. n
ELI:00029 Validity: Not mentioned, issued in 516400 Light
Oct. 2022 1 Source
R&I details

Decisions of 85th Meeting of MDB (21-03-2025) Page 66 of 138

 Date: LOA LED 2.2
21/12/2022 Validity: 31/12/2025 80W
Slip no. Fiber Light
651044546250 806550 Cable
Rs. 5000. 35 5MM TL
3.5M
Adapter
8095.07 Projector
Side
Adapter
809509 Endoscope
Side
121. M/s. Allmed Legal Manufacturer: KARL STORZ Lasers Deferred since
Solutions KARL STORZ SE & CO. KG (Laser Devices, Foot Switches for multiple products
Address: Germany Laser, Laser Fibers (sterile/non- applied including
A-21/3, KDA sterile)) both sterile and non
Scheme No.1 Address: Dr.-Karl-Storz- StraBe 34 sterile.
(ext) Stadium 78532 Tuttlingen, Germany Class B
Road, Karachi
LOA Shelf Life: N/A
ELI-00029 Validity: 31/12/2025
Codes / Sizes:
R&I Details: FSC:
Date: Country of Origin Article Name
02/11/2022 Validity: Not mentioned, issued in LASER
Slip no. Oct. 2022 27840L
Hand
1509539734 I
Instrument
Rs. 25,000/- LASER
FSC: Application
FSC of Reference Country US 8694
Instrument,
Validity: not mentioned 23 cm
OR LEUNIG-
GREVERS
EC Certificate 461000
LASER
Validity: 17-12-2025 Application
Sheath
ISO 13485 f.LASER
Validity: 31-05-2025 1218AL
probe and
1218A/AA
Sheath
f.LASER
1218BL
probe and
1218B/BA
Inner Tube
27040X
for 27040
AL
SD/SL
Laser
27042L working
V element for
vaporisation
Laser
working
27042V
element for
vaporisation
LASER
27050V
Working
L
Insert
27056E LASER

Decisions of 85th Meeting of MDB (21-03-2025) Page 67 of 138

 A Guide Probe,
0.8 mm
LASER
27056E
Guide Probe,
B
1.5 mm
LASER
27056E
Guide Probe,
C
0.8 mm
LASER
27056E
Guide Probe,
D
1.5 mm
27056L Working
A Element
KUNTZ
27056L
Working
B
Element
LASER
27056L
Working
E
Element
Laser-suction
27290L
tube, outer
A
sheath
Motion
27290L
control
I
device
SCHERER
LASER
722010A
Rhinoscope
Sheath 0°
SCHERER
LASER
722010B
Rhinoscope
Sheath, 30°
LASER
Mirror,
8597P
Epipharynx,
20 mm

122. M/s. Allmed Legal Manufacturer: KARL STORZ Motors Deferred since
Solutions KARL STORZ SE & CO. KG (Motor Control Unit, multiple products
Address: Germany Handpieces/Motors, Foot Switches applied including
A-21/3, KDA for Motor Control Unit, both sterile and non
Scheme No.1 Address: Dr.-Karl-Storz- StraBe 34 Shaver/Drills (sterile/non-sterile)) sterile.
(ext) Stadium 78532 Tuttlingen, Germany
Road, Karachi Class A
FSC: Germany
ELI:00029 Validity: Not mentioned, issued in Shelf Life: N/A
Oct. 2022
R&I details Codes / Sizes
Date: LOA Article Description
03/01/2023 Validity: 31/12/2025
Slip no. UM100 PowerUnit
777237723643 Handle for
Rs. 5000. DRILLCUT
407120 -X II
90 Handpieces
207116 Irrigation

Decisions of 85th Meeting of MDB (21-03-2025) Page 68 of 138

 80 rod for
Unidrive
ENT
123. M/s. RECH Legal Manufacturer: Brand: Soprano Approved subject to
International M/s Beijing Libeier Bio-engineering Posterior cervical screw rod system provision of codes.
Address: Institute Co., Ltd. 12 Chuangxin instrument set
247/B, BLOCK Road, Changping Science and Generic:
6 P.E.C.H.S, Technology Park, Changping Area, Orthopedic Manual Surgical
Karachi Beijing, P. R. China. Instrument Set

ELI: 00257 FSC validity: Class A

26-10-2026 Shelf Life: N/A
R&I details Models:
Date: 18-01- LOA Validity: As per FSC
2024 31/12/2026

Slip no.
064446774245
PKR 5000/-
Dated: 22-12-
2023

124. M/s. RECH Legal Manufacturer: Brand: Soprano Approved subject to

International M/s Beijing Libeier Bio-engineering Posterior cervical screw rod system provision of codes.
Address: Institute Co., Ltd. 12 Chuangxin instrument set
247/B, BLOCK Road, Changping Science and Generic:
6 P.E.C.H.S, Technology Park, Changping Area, Orthopedic Manual Surgical
Karachi Beijing, P. R. China. Instrument Set

ELI: 00257 FSC validity: Class A

26-10-2026 Shelf Life: N/A
R&I details Models:
Date: 18-01- LOA Validity: As per FSC
2024 31/12/2026

Slip no.
064446774245
PKR 5000/-
Dated: 22-12-
2023

125. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Thyroid Stimulating Hormone (e Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, CLIA) free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Class B as well as Reference
Blue Area, Shenzhen City, Guangdong Size/specification: regulatory body or
Islamabad Province, 518055, P.R China. 50T, 2x50T, 100T, 2x100T CE certificate.
(ELI-00926) LOA validity:
Date of R&I: ISO 13485 certificate validity: 25- 31-12-2027
26-10-2023 03-2024
Fee Challan Shelf Life: 12 months
No.:
62334559588 ISO 13485 Validity:
PKR: 25000/- 13-12-2026
Dated: 26-12-

Decisions of 85th Meeting of MDB (21-03-2025) Page 69 of 138

 2022

126. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Total Triiodothyronine Kit (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body/ CE
Islamabad Province, 518055, P.R China. LOA validity: certificate
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
7186517086 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

127. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Total Beta Human Chrionic Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, Gonadotropin (Total β-HCG) (e free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 CLIA) for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, as well as Reference
Blue Area, Shenzhen City, Guangdong Class B regulatory body.
Islamabad Province, 518055, P.R China. Size/specification:
(ELI-00926) 50T, 2x50T, 100T, 2x100T
Date of R&I: ISO 13485 certificate validity: 25- LOA validity:
26-10-2023 03-2024 31-12-2027
Fee Challan
No.: Shelf Life: 12 months
476494378
PKR: 25000/- ISO 13485 Validity:
Dated: 26-12- 13-12-2026
2022

128. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Testosterone (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
3159985437 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

129. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Prolactin (e CLIA) Legalized & valid

Decisions of 85th Meeting of MDB (21-03-2025) Page 70 of 138

 2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
5305306014 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

130. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Free Triiodothyronine Kit (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
402484508 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

131. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Free Thyroxine Kit (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
44087136672 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

132. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Ferritin Kit (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:

Decisions of 85th Meeting of MDB (21-03-2025) Page 71 of 138

 (ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 12 months
Fee Challan
No.: ISO 13485 Validity:
69556614557 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

133. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Enhanced Washing Buffer Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class B for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50mL; 2x50mL regulatory body.
Islamabad Province, 518055, P.R China. LOA validity:
(ELI-00926) 31-12-2027
Date of R&I: ISO 13485 certificate validity: 25-
26-10-2023 03-2024 Shelf Life: 24 months
Fee Challan
No.: ISO 13485 Validity:
41294489319 13-12-2026
PKR: 25000/-
Dated: 26-12-
2022

134. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd Assay Cup Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class A for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 300 T regulatory body.
Islamabad Province, 518055, P.R China. 3000 T
(ELI-00926) LOA validity:
Date of R&I: ISO 13485 certificate validity: 25- 31-12-2027
26-10-2023 03-2024
Fee Challan Shelf Life: 24 months
No.:
3255837633 ISO 13485 Validity:
PKR: 5000/- 13-12-2026
Dated: 26-12-
2022

135. M/s Moody Manufacturing site: Brand: Lifotronic Approved Subject To

Global Services. M/s Shenzhen Lifotronic Generic: Submission Of
Office No 14, Technology Co., Ltd 25-OH Vitamin D Total (e CLIA) Legalized & valid
2nd Floor, Address: Unit A, 4th Floor, free sale certificate
Mujahid Plaza, Building 15, Yijing Estate, No 1008 Class A for country of origin
Jinnah Avenue, Songbai Road, Nanshan District, Size/specification: as well as Reference
Blue Area, Shenzhen City, Guangdong 50T, 2x50T, 100T, 2x100T regulatory body.
Islamabad Province, 518055, P.R China.
(ELI-00926) LOA validity:
Date of R&I: ISO 13485 certificate validity: 25- 31-12-2027
26-10-2023 03-2024
Fee Challan Shelf Life: 12 months
No.:

Decisions of 85th Meeting of MDB (21-03-2025) Page 72 of 138

 3255837633 ISO 13485 Validity:
PKR: 25000/- 13-12-2026
Dated: 26-12-
2022

136. Applicant: (Legal Manufacturer) SYSMEX Approved .

M/s S. Name: HISCL FT3 Assay Kit with
Ejazuddin & M/s SYSMEX CORPORATION Calibrator & Consumables
Co., 1-5-1 WakinohamaKaigandori,
237-B, Block II, Chuo-ku, Kobe 651-0073, Japan. Code: AJ-162-809 HISCL FT3
PECHS, Assay Kit
Shahrahe- ISO 13485 Certificate validity: 15- Class B
Quaideen, 08-2027 Shelf Life: 12 months
Karachi.
(ELI-00078) Code: 054-2411-7 HISCL FT3
R& I Date: Letter of authorization: Calibrator
23-07-2020 13-12-2025 Class B
Fee details: Shelf Life: 12 months
Amount: PKR
25000/- FSC Japan issued on: Code: 064-4331-9 HISCL Substrate
Slip: 2030402 25-10-2019 Reagent Set
Dated: (14-07- Class B
2020) Shelf Life: 12 months

Code: 054-2361-8 HISCL Washing

Solution
Class A
Shelf Life: 12 months

Code: CH-219-079 HISCL Washing

Solution
Class A
Shelf Life: 12 months

137. Applicant: (Legal Manufacturer) SYSMEX Approved .

M/s S. Name: HISCL Insulin Assay Kit with
Ejazuddin & M/s SYSMEX CORPORATION Calibrator & Consumables
Co., 1-5-1 WakinohamaKaigandori,
237-B, Block II, Chuo-ku, Kobe 651-0073, Japan. Code: CV-679-198 HISCL Insulin
PECHS, Assay Kit
Shahrahe- ISO 13485 Certificate validity: 15- Class B
Quaideen, 08-2027 Shelf Life: 12 months
Karachi.
(ELI-00078) Code: BW-351-765 HISCL Insulin
R& I Date: Letter of authorization: Calibrator
18-08-2020 13-12-2025 Class B
Fee details: Shelf Life: 12 months
Amount: PKR
25000/- FSC Japan issued on: Code: CS-617-657 HISCL Diluent
Slip: 2030412 25-10-2019 Class A
Dated: 04-08- Shelf Life: 12 months
2020
Code: 064-4331-9 HISCL Substrate
Reagent Set
Class B
Shelf Life: 12 months

Code: 054-2361-8 HISCL Washing

Solution

Decisions of 85th Meeting of MDB (21-03-2025) Page 73 of 138

 Class A
Shelf Life: 12 months

Code: CH-219-079 HISCL Washing

Solution
Class A
Shelf Life: 12 months

138. Applicant: (Legal Manufacturer) SYSMEX Approved .

M/s S. Name: HISCL TSH Assay Kit with
Ejazuddin & M/s SYSMEX CORPORATION Calibrator & Consumables
Co., 1-5-1 WakinohamaKaigandori,
237-B, Block II, Chuo-ku, Kobe 651-0073, Japan. Code: BB-600-695 HISCL TSH
PECHS, Assay Kit
Shahrahe- ISO 13485 Certificate validity: 15- Class B
Quaideen, 08-2027 Shelf Life: 12 months
Karachi.
(ELI-00078) Code: 054-2441-9 HISCL TSH
R& I Date: Letter of authorization: Calibrator
18-08-2020 13-12-2025 Class B
Fee details: Shelf Life: 12 months
Amount: PKR
25000/- FSC Japan issued on: Code: CS-617-657 HISCL Diluent
Slip: 2030411 25-10-2019 Class A
Dated: 04-08- Shelf Life: 12 months
2020
Code: 064-4331-9 HISCL Substrate
Reagent Set
Class B
Shelf Life: 12 months

Code: 054-2361-8 HISCL Washing

Solution
Class A
Shelf Life: 12 months

Code: CH-219-079 HISCL Washing

Solution
Class A
Shelf Life: 12 months

139. Applicant: (Legal Manufacturer) SYSMEX Approved .

M/s S. Name: HISCL FT4 Assay Kit with
Ejazuddin & M/s SYSMEX CORPORATION Calibrator & Consumables
Co., 1-5-1 WakinohamaKaigandori,
237-B, Block II, Chuo-ku, Kobe 651-0073, Japan. 1Code: CB-825-811 HISCL FT4
PECHS, Assay Kit
Shahrahe- ISO 13485 Certificate validity: 15- Class B
Quaideen, 08-2027 Shelf Life: 12 months
Karachi.
(ELI-00078) Code: 054-2381-2 HISCL FT4
R& I Date: Letter of authorization: Calibrator
18-08-2020 13-12-2025 Class B
Fee details: Shelf Life: 12 months
Amount: PKR
25000/- FSC Japan issued on: Code: 064-4331-9 HISCL Substrate
Slip: 2030416 25-10-2019 Reagent Set
Dated: 16-10- Class B
2020 Shelf Life: 12 months

Decisions of 85th Meeting of MDB (21-03-2025) Page 74 of 138

 Code: 054-2361-8 HISCL Washing
Solution
Class A
Shelf Life: 12 months

Code: CH-219-079 HISCL Washing

Solution
Class A
Shelf Life: 12 months

140. Applicant: (Legal Manufacturer) Semi-automated Blood Coagulation Approved .

M/s S. Name: Analyzer CA-104 along with
Ejazuddin & M/s LABiTec LAbor BioMedical Accessories & Consumables
Co., Technologies GmbH
237-B, Block II, An der Strusbek 6 22926 Class A
PECHS, Ahrensburg Germany. Shelf Life: N/A
Shahrahe-
Quaideen, ISO 13485 Certificate validity: Codes: CP944871 / Sizes (if any)
Karachi. 09.07.2027 Accessories & Consumables:
(ELI-00078)
R& I Date: Cuvette FL
23-03-2023 Letter of authorization: Code: AG405069
Fee details: 01.04 2025
Amount: PKR Cuvette FL
5000/- Code: BD900346
Slip: FSC Germany issued on:
049279101703 13.09.2019 CA-104 Thermal Paper
Dated: 21-03- Code: AC845489
2023
DIN 18 Siliconized 8 mL White
Code: CE414580

Cuv CARD FOR CA1

Code: CV198522

141. Applicant: (Legal Manufacturer) Semi-automated Blood Coagulation Approved .

M/s S. Name: Analyzer CA-101 along with
Ejazuddin & M/s LABiTec LAbor BioMedical Accessories & Consumables
Co., Technologies GmbH
237-B, Block II, An der Strusbek 6 22926 Class A
PECHS, Ahrensburg Germany. Shelf Life: N/A
Shahrahe-
Quaideen, ISO 13485 Certificate validity: Codes:
Karachi. 09.07.2027 BX533278 / Sizes (if any)
(ELI-00078) Accessories & Consumables:
R& I Date:
30.03.2020 Letter of authorization: SUL-400A Cuvette FL Complete
Fee details: 01.04 2025 Code: AG405069
Amount: PKR
5000/- Cuvette FL FOR CA1
Slip: 1945894 FSC Germany issued on: Code: BD900346
Dated: 13.09.2019
18.03.2020 CA-104 Thermal Paper
Code: AC845489

DIN 18 Siliconized 8 mL White

Code: CE414580

Decisions of 85th Meeting of MDB (21-03-2025) Page 75 of 138

 Cuv CARD FOR CA1
Code: CV198522

142. Applicant: (Legal Manufacturer) Sysmex Approved .

M/s S. Name:
Ejazuddin & M/s SYSMEX CORPORATION 1- Controls for Sysmex Automated
Co., 5-1 Wakinohama-Kaigandori, Hematology Analyzer XN-31
236-C, Block II, Chuoku, Kobe 651-0073, Japan.
PECHS, Code:
Shahrahe- ISO 13485 Certificate validity: AF640985  XN CHECK L1
Quaideen, 09.07.2027 CV649926  XN CHECK L2
Karachi. BV166979  XN CHECK L3
(ELI-00078)
R& I Date: Letter of authorization: Class B
23-05-2024 01.04 2025 Shelf Life: 12 month
Fee details:
Amount: PKR
25000/- FSC Germany issued on:
Slip: 13.09.2019
2827736224
Dated: 16-05-
2024
143. Applicant: (Legal Manufacturer) Sysmex Approved .
M/s S. Name:
Ejazuddin & M/s SYSMEX CORPORATION 1- Reagents & Controls of Sysmex XR-
Co., 5-1 Wakinohama-Kaigandori, Series Automated Hematology
236-C, Block II, Chuoku, Kobe 651-0073, Japan. Analyzers
PECHS,
Shahrahe- ISO 13485 Certificate validity: Code: BY541589
Quaideen, 09.07.2027 Name: Lysercell WDF II
Karachi. Shelf life: 12 months
(ELI-00078) Open vial: 90 days
R& I Date: Letter of authorization:
06-12-2024 01.04 2025 Code: 904-1141-4
Fee details: Name: SULFOLYSER
Amount: PKR Shelf life: 12 months
31000/- FSC Germany issued on: Open vial: 90 days
Slip: 13.09.2019
2827736224 Code: ZPPBY541589
Dated: 28-11- Name: Lysercell WDF II
2024 Shelf life: 12 months
Open vial: 90 days

Code: 230303
Name: WRP CHECK EX
Shelf life: 93 days
Open vial: 05 days

Class B

144. Applicant: (Legal Manufacturer) Cellagon 03 Approved .

M/s Name: Hematology Analyzer (g-Cell3)
BIOMADICS. M/s Diagon Ltd. Manufacturer
Gate #1, 211/B Address: No. H – 1047Budapest, Code: (g-Cell3) Cellagon – 03
Sindhi Muslim Baross u, Street 48 – 52, Hungary. Hematology Analyzer
Corporation
Housing FSC Hungary: Class A
Society, Block issued on 10.07.2020 Letter of authorization:
B, Karachi 30-07-2026

Decisions of 85th Meeting of MDB (21-03-2025) Page 76 of 138

 (ELI-00432)
Fee details:
Amount: PKR
5000/-
Slip:
20637661382
Dated: 26-01-
2023
145. Applicant: (Legal Manufacturer) Cellagon 03 Approved .
M/s Name: Hematology Analyzer Reagents
BIOMADICS. M/s Biocytech Corporation sdn. bhd Model:
Gate #1, 211/B Manufacturer Address: No.820, 1. Cellaton – D (h73101)
Sindhi Muslim Simpang Empat, Jalan Lahat, 31450 2. Cellalyse (h73102)
Corporation Menglembu, Ipoh, Perak, Malaysia. 3. CellaClean (h73136)
Housing 4. D-Check D 2.5 Low (DDC-
Society, Block FSC Hungary: 18T2,5 L)
B, Karachi issued on 18-09.2020 5. D-Check D 2.5 Normal (DDC-
(ELI-00432) 18T2,5 N)
Fee details: Letter of authorization: 6. D-Check D 2.5 High (DDC-
Amount: PKR 30-07-2026 18T2,5 H)
5000/- 7. D-Cal D (DCALD3,0)
Slip: Class A
973264749228 Shelf life: 02 years
Dated: 26-01-
2023
146. Applicant: (Legal Manufacturer) PATHTEZT PAP SMEAR Approved .
M/s Name: COLLECTION TEST KIT
BIOMADICS. M/s Biocytech Corporation sdn. bhd
Gate #1, 211/B Manufacturer Address: No.820, (PAP SMEAR TEST
Sindhi Muslim Simpang Empat, Jalan Lahat, 31450 INSTRUMENT)
Corporation Menglembu, Ipoh, Perak, Malaysia. Model:
Housing 1. Preserve Cell Solution 20ML
Society, Block FSC Hungary: (PCS-200920)
B, Karachi issued on 18-09.2020
(ELI-00432) 2. Non-Gyn Preserve Cell Solution
Fee details: Letter of authorization: 20ML (NGPCS-200920)
Amount: PKR 30-07-2026
5000/- 3. Preserve Cell Solution 926ML
Slip: (PCS-926)
0916890539
Dated: 30-07- 4. Cytolysis Solution 926ML
2021 (CTLS-9260604)

5. Filter-Slide Test (FST-36100)

6. Non-Gyn Filter-Slide Test

(NFST-5100)

7. Gyn Filter (GF-0825100)

8. Non-Gyn Filter (NGF-0525100)

9. Urine Cell Filter (UCF-0813100)

10. Cyto Slide (CS-36100)

11. Pretreatment Kit (Pre-Filter)

(PS-250)

Decisions of 85th Meeting of MDB (21-03-2025) Page 77 of 138

 Class A
Shelf life: 02 years

147. Applicant: (Legal Manufacturer) Fetal Doppler System Deferred for

M/s : TRI Name: submission of
TECH M/s Bistos, 7th Floor, A Bldg, Model: BT-250 documents from legal
INTERNATIO Woolim Lions Valley 5-cha, 302, Class B manufacturer i.e.
NAL Galmachi-ro, Jungwon- gu, Shelf life: 05 years valid and legalized
10 C 6 Sungnam-si, Gyeonggi-do, Korea. free sale certificate,
SUNSET EC Certificate: expired EC certificate, ISO
COMM LINE FSC Korea: ISO 13485 Certificate validity: 13485 certificate
PHASE II issued on 30-01-2020 expired along with
DEFENCE declaration of
HOUSING Letter of authorization: conformity.
AUTHORITY 26-06-2028
KARACHI
(ELI-00247)
Fee details:
Amount: PKR
25000/-
Slip: 2006272
Dated: 09-07-
2020

148. Applicant: (Legal Manufacturer) Promed Stomach Tube Approved subject to

M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: FR 6, FR 8, FR 10, FR 12, valid FSC
ENTERPRISES LTD. FR 14, FR 16, FR 18, FR 20, FR 22
Plot No. 331-C, 1st Floor of Building No. 2, Class B
Block 3, Building No. 4, Longzhu Village Shelf life: 05 years
DMCH Society, Economic Estate, Longzhu Avenue,
Alamgir Road, Nanlang, 528451 Zhongshan, EC Certificate validity:
Karachi Guangdong, Peoples’s Republic of 26-05-2024
(ELI-00252) China
Date of R&I: FSC China: ISO 13485 Certificate validity: 31-
23-12-2024 Validity: 24-10-2025 07-2025
Fee details: FSC (RRA) UK Letter of authorization:
Submitted 26-06-2028

149. Applicant: (Legal Manufacturer) Promed Feeding Tube Approved subject to

M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: FR 4, FR 5, FR 6, FR 8, FR valid FSC
ENTERPRISES LTD. 10, FR 12, FR 14, FR 16, FR 18, FR
Plot No. 331-C, 1st Floor of Building No. 2, 20
Block 3, Building No. 4, Longzhu Village Class B
DMCH Society, Economic Estate, Longzhu Avenue, Shelf life: 05 years
Alamgir Road, Nanlang, 528451 Zhongshan,
Karachi Guangdong, Peoples’s Republic of EC Certificate validity:
(ELI-00252) China 26-05-2024
Date of R&I: FSC China:
23-12-2024 Validity: 24-10-2025 ISO 13485 Certificate validity: 31-
Fee details: FSC (RRA) UK 07-2025
Submitted Letter of authorization:
26-06-2028

Decisions of 85th Meeting of MDB (21-03-2025) Page 78 of 138

150. Applicant: (Legal Manufacturer) Promed Suction Catheter Approved subject to
M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: valid FSC
ENTERPRISES LTD. Mucus Extractor type: Sizes: FR 6,
Plot No. 331-C, 1st Floor of Building No. 2, FR 8, FR 10, FR 12, FR 14, FR 16,
Block 3, Building No. 4, Longzhu Village FR 18, FR 20
DMCH Society, Economic Estate, Longzhu Avenue,
Alamgir Road, Nanlang, 528451 Zhongshan, Normal: Sizes: FR 5, FR 6, FR 8,
Karachi Guangdong, Peoples’s Republic of FR 10, FR 12, FR 14, FR 16, FR 18,
(ELI-00252) China FR 20, FR 22
Date of R&I: FSC China: Class B
23-12-2024 Validity: 24-10-2025 Shelf life: 05 years
Fee details: FSC (RRA) UK
Submitted EC Certificate validity:
26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

151. Applicant: (Legal Manufacturer) Promed Yankauer Suction Set Approved subject to
M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: Yankauer Suction handle eith valid FSC
ENTERPRISES LTD. suction connecting tube Sizes:
Plot No. 331-C, 1st Floor of Building No. 2, 9/32’’ , 1/4 ” , 3/16’’
Block 3, Building No. 4, Longzhu Village
DMCH Society, Economic Estate, Longzhu Avenue, Class B
Alamgir Road, Nanlang, 528451 Zhongshan, Shelf life: 05 years
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China EC Certificate validity:
Date of R&I: FSC China: 26-05-2024
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK ISO 13485 Certificate validity: 31-
Submitted 07-2025
Letter of authorization:
26-06-2028

152. Applicant: (Legal Manufacturer) Promed Nasal Oxygen Cannula Approved subject to
M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: Yankauer Suction handle eith valid FSC
ENTERPRISES LTD. suction connecting tube Sizes:
Plot No. 331-C, 1st Floor of Building No. 2, 9/32’’ , 1/4 ” , 3/16’’
Block 3, Building No. 4, Longzhu Village
DMCH Society, Economic Estate, Longzhu Avenue, Class B
Alamgir Road, Nanlang, 528451 Zhongshan, Shelf life: 05 years
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China EC Certificate validity:
Date of R&I: FSC China: 26-05-2024
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK ISO 13485 Certificate validity: 31-
Submitted 07-2025
Letter of authorization:
26-06-2028

153. Applicant: (Legal Manufacturer) Promed Nebulizer with Aerosol Approved subject to
M/S Name: Mask fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: Adult standard, Pediatric

Decisions of 85th Meeting of MDB (21-03-2025) Page 79 of 138

 Plot No. 331-C, 1st Floor of Building No. 2, Standard, Adult elongated, Pediatric
Block 3, Building No. 4, Longzhu Village elongated, Infant
DMCH Society, Economic Estate, Longzhu Avenue,
Alamgir Road, Nanlang, 528451 Zhongshan, Class B
Karachi Guangdong, Peoples’s Republic of Shelf life: 05 years
(ELI-00252) China
Date of R&I: FSC China: EC Certificate validity:
23-12-2024 Validity: 24-10-2025 26-05-2024
Fee details: FSC (RRA) UK
Submitted ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

154. Applicant: (Legal Manufacturer) Promed Non-Rebreathing Mask Approved subject to

M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: Adult standard, Pediatric valid FSC
ENTERPRISES LTD. Standard, Adult elongated, Pediatric
Plot No. 331-C, 1st Floor of Building No. 2, elongated, Infant
Block 3, Building No. 4, Longzhu Village
DMCH Society, Economic Estate, Longzhu Avenue, Class B
Alamgir Road, Nanlang, 528451 Zhongshan, Shelf life: 05 years
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China EC Certificate validity:
Date of R&I: FSC China: 26-05-2024
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK ISO 13485 Certificate validity: 31-
Submitted 07-2025
Letter of authorization:
26-06-2028

155. Applicant: (Legal Manufacturer) Promed Oxygen Mask Approved subject to

M/S Name: fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Sizes: Adult standard, Pediatric valid FSC
ENTERPRISES LTD. Standard, Adult elongated, Pediatric
Plot No. 331-C, 1st Floor of Building No. 2, elongated, Infant
Block 3, Building No. 4, Longzhu Village
DMCH Society, Economic Estate, Longzhu Avenue, Class B
Alamgir Road, Nanlang, 528451 Zhongshan, Shelf life: 05 years
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China EC Certificate validity:
Date of R&I: FSC China: 26-05-2024
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK ISO 13485 Certificate validity: 31-
Submitted 07-2025
Letter of authorization:
26-06-2028

156. Applicant: (Legal Manufacturer) Promed Standard Endotracheal Tube Approved subject to
M/S Name: - Cuffed fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: 2.5mm, 3.0mm, 3.5mm,
Plot No. 331-C, 1st Floor of Building No. 2, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0
Block 3, Building No. 4, Longzhu Village mm, 6.5 mm, 7.0mm, 7.5mm, 8.0
DMCH Society, Economic Estate, Longzhu Avenue, mm, 8.5mm, 9.0mm, 9.5mm,
Alamgir Road, Nanlang, 528451 Zhongshan, 10.0mm
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China Class B
Date of R&I: FSC China: Shelf life: 05 years

Decisions of 85th Meeting of MDB (21-03-2025) Page 80 of 138

 23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK EC Certificate validity:
Submitted 26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

157. Applicant: (Legal Manufacturer) Promed Standard Endotracheal Tube Approved subject to
M/S Name: - Uncuffed fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: 2.0mm, 2.5mm, 3.0mm,
Plot No. 331-C, 1st Floor of Building No. 2, 3.5mm, 4.0mm, 4.5mm, 5.0mm,
Block 3, Building No. 4, Longzhu Village 5.5mm, 6.0 mm, 6.5 mm, 7.0mm,
DMCH Society, Economic Estate, Longzhu Avenue, 7.5mm, 8.0 mm, 8.5mm, 9.0mm,
Alamgir Road, Nanlang, 528451 Zhongshan, 9.5mm, 10.0mm
Karachi Guangdong, Peoples’s Republic of
(ELI-00252) China Class B
Date of R&I: FSC China: Shelf life: 05 years
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK EC Certificate validity:
Submitted 26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

158. Applicant: (Legal Manufacturer) Promed Oral Preformed Approved subject to

M/S Name: Endotracheal Tube – Cuffed fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: 3.0mm, 3.5mm, 4.0mm,
Plot No. 331-C, 1st Floor of Building No. 2, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5
Block 3, Building No. 4, Longzhu Village mm, 7.0mm, 7.5mm, 8.0 mm,
DMCH Society, Economic Estate, Longzhu Avenue, 8.5mm, 9.0mm, 9.5mm, 10.0mm
Alamgir Road, Nanlang, 528451 Zhongshan,
Karachi Guangdong, Peoples’s Republic of Class B
(ELI-00252) China Shelf life: 05 years
Date of R&I: FSC China:
23-12-2024 Validity: 24-10-2025 EC Certificate validity:
Fee details: FSC (RRA) UK 26-05-2024
Submitted
ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

159. Applicant: (Legal Manufacturer) Promed Nasal Preformed Approved subject to

M/S Name: Endotracheal Tube – Cuffed fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: 3.0mm, 3.5mm, 4.0mm,
Plot No. 331-C, 1st Floor of Building No. 2, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5
Block 3, Building No. 4, Longzhu Village mm, 7.0mm, 7.5mm, 8.0 mm,
DMCH Society, Economic Estate, Longzhu Avenue, 8.5mm, 9.0mm, 9.5mm, 10.0mm
Alamgir Road, Nanlang, 528451 Zhongshan,
Karachi Guangdong, Peoples’s Republic of Class B
(ELI-00252) China Shelf life: 05 years
Date of R&I: FSC China:

Decisions of 85th Meeting of MDB (21-03-2025) Page 81 of 138

 23-12-2024 Validity: 24-10-2025 EC Certificate validity:
Fee details: FSC (RRA) UK 26-05-2024
Submitted
ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

160. Applicant: (Legal Manufacturer) Promed Reinforced Endotracheal Approved subject to

M/S Name: Tube - Cuffed fee verification and
MEDICHEM M/s BONREE MEDICAL CO. valid FSC
ENTERPRISES LTD. Sizes: 3.0mm, 3.5mm, 4.0mm,
Plot No. 331-C, 1st Floor of Building No. 2, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5
Block 3, Building No. 4, Longzhu Village mm, 7.0mm, 7.5mm, 8.0 mm,
DMCH Society, Economic Estate, Longzhu Avenue, 8.5mm, 9.0mm, 9.5mm, 10.0mm
Alamgir Road, Nanlang, 528451 Zhongshan,
Karachi Guangdong, Peoples’s Republic of Class B
(ELI-00252) China Shelf life: 05 years
Date of R&I: FSC China:
23-12-2024 Validity: 24-10-2025 EC Certificate validity:
Fee details: FSC (RRA) UK 26-05-2024
Submitted
ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

161. Applicant: (Legal Manufacturer) Promed Endotracheal Tube Approved subject to

M/S Name: Introducer (Bougie) / Intubating fee verification and
MEDICHEM M/s BONREE MEDICAL CO. Stylet valid FSC
ENTERPRISES LTD.
Plot No. 331-C, 1st Floor of Building No. 2, Sizes:
Block 3, Building No. 4, Longzhu Village 1. Endotracheal Tube Introducer
DMCH Society, Economic Estate, Longzhu Avenue, (Bougie):
Alamgir Road, Nanlang, 528451 Zhongshan, A. Hollow Type: Sizes: FR 10, FR
Karachi Guangdong, Peoples’s Republic of 15
(ELI-00252) China B. Solid Type: Sizes: FR 6, FR 10,
Date of R&I: FSC China: FR 15
23-12-2024 Validity: 24-10-2025
Fee details: FSC (RRA) UK 2. Intubating Stylet:
Submitted Sizes: FR 6, FR 10, FR 12, FR 14
Class B
Shelf life: 05 years

EC Certificate validity:
26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

162. Applicant: (Legal Manufacturer) Promed Endobronchial Tube Approved subject to

M/S Name: fee verification and
MEDICHEM M/S GUANGDONG ECAN Type: valid FSC
ENTERPRISES MEDICAL CO., LTD. 1. Standard Right Sided
Plot No. 331-C, Building 1, No. 222, Xindu Road, 2. Standard Left Sided
Block 3, Chengjiao Street, Conghua District, Sizes Available: 26Fr, 28 Fr, 32 Fr,
DMCH Society, Guangzhou City, Guangdong 35Fr, 37Fr, 39Fr, 41Fr, 42Fr

Decisions of 85th Meeting of MDB (21-03-2025) Page 82 of 138

 Alamgir Road, Province, 510920, P.R. China Class B
Karachi FSC China: Shelf life: 05 years
(ELI-00252) Validity: 21-10-2026
Date of R&I: FSC (RRA) UK EC Certificate validity:
23-12-2024 Validity: 30-06-2029 26-05-2024
Fee details:
ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

163. Applicant: (Legal Manufacturer) Promed Tracheostomy Tube Approved subject to

M/S Name: fee verification and
MEDICHEM M/S GUANGDONG ECAN Type: valid FSC
ENTERPRISES MEDICAL CO., LTD. 1. Standard Cuffed
Plot No. 331-C, Building 1, No. 222, Xindu Road, 2. Standard Uncuffed
Block 3, Chengjiao Street, Conghua District, Sizes available: 3.0mm, 3.5mm,
DMCH Society, Guangzhou City, Guangdong 4.0mm, 4.5mm, 5.0mm, 5.5mm,
Alamgir Road, Province, 510920, P.R. China 6.0mm, 6.5mm, 7.0mm, 7.5mm,
Karachi FSC China: 8.0mm, 8.5mm. 9.0mm, 9.5mm,
(ELI-00252) Validity: 21-10-2026 10.0mm
Date of R&I: FSC (RRA) UK Class B
23-12-2024 Validity: 30-06-2029 Shelf life: 05 years
Fee details:
EC Certificate validity:
26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

164. Applicant: (Legal Manufacturer) Promed Laryngeal Mask Device Approved subject to
M/S Name: fee verification and
MEDICHEM M/S GUANGDONG ECAN Type: valid FSC
ENTERPRISES MEDICAL CO., LTD. 1. Standard Grilled
Plot No. 331-C, Building 1, No. 222, Xindu Road, 2. Standard Ungrilled
Block 3, Chengjiao Street, Conghua District, 3. Reinforced Grilled
DMCH Society, Guangzhou City, Guangdong 4. Reinforced Ungrilled
Alamgir Road, Province, 510920, P.R. China Sizes Available: 1#, 1.5#, 2#, 2.5#,
Karachi FSC China: 3#, 4#, 5#
(ELI-00252) Validity: 21-10-2026 Class B
Date of R&I: FSC (RRA) UK Shelf life: 05 years
23-12-2024 Validity: 30-06-2029
Fee details: EC Certificate validity:
26-05-2024

ISO 13485 Certificate validity: 31-

07-2025
Letter of authorization:
26-06-2028

165. Applicant: (Legal Manufacturer) Promed 2-Way Latex Foley Catheter Approved subject to
M/S Name: Sizes: 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, fee verification and
MEDICHEM M/S GUANGDONG ECAN 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, valid FSC
ENTERPRISES MEDICAL CO., LTD. 28Fr, 30Fr
Plot No. 331-C, Building 1, No. 222, Xindu Road, Class B
Block 3, Chengjiao Street, Conghua District, Shelf life: 05 years
DMCH Society, Guangzhou City, Guangdong

Decisions of 85th Meeting of MDB (21-03-2025) Page 83 of 138

 Alamgir Road, Province, 510920, P.R. China EC Certificate validity:
Karachi FSC China: 26-05-2024
(ELI-00252) Validity: 21-10-2026
Date of R&I: FSC (RRA) UK ISO 13485 Certificate validity: 31-
23-12-2024 Validity: 30-06-2029 07-2025
Fee details: Letter of authorization:
26-06-2028

166. Applicant: (Legal Manufacturer) Promed 3-Way Latex Foley Catheter Approved subject to
M/S Name: Sizes: 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, fee verification and
MEDICHEM M/S GUANGDONG ECAN 24Fr, 26Fr valid FSC
ENTERPRISES MEDICAL CO., LTD. Class B
Plot No. 331-C, Building 1, No. 222, Xindu Road, Shelf life: 05 years
Block 3, Chengjiao Street, Conghua District,
DMCH Society, Guangzhou City, Guangdong EC Certificate validity:
Alamgir Road, Province, 510920, P.R. China 26-05-2024
Karachi FSC China:
(ELI-00252) Validity: 21-10-2026 ISO 13485 Certificate validity: 31-
Date of R&I: FSC (RRA) UK 07-2025
23-12-2024 Validity: 30-06-2029 Letter of authorization:
Fee details: 26-06-2028

167. Applicant: (Legal Manufacturer) Promed 2-Way Silicon Foley Approved subject to
M/S Name: Catheter fee verification and
MEDICHEM M/S GUANGDONG ECAN Sizes: 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, valid FSC
ENTERPRISES MEDICAL CO., LTD. 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr,
Plot No. 331-C, Building 1, No. 222, Xindu Road, 28Fr, 30Fr
Block 3, Chengjiao Street, Conghua District, Class B
DMCH Society, Guangzhou City, Guangdong Shelf life: 05 years
Alamgir Road, Province, 510920, P.R. China
Karachi FSC China: EC Certificate validity:
(ELI-00252) Validity: 21-10-2026 26-05-2024
Date of R&I: FSC (RRA) UK
23-12-2024 Validity: 30-06-2029 ISO 13485 Certificate validity: 31-
Fee details: 07-2025
Letter of authorization:
26-06-2028

168. Applicant: (Legal Manufacturer) Promed 3-Way Silicon Foley Approved subject to
M/S Name: Catheter fee verification and
MEDICHEM M/S GUANGDONG ECAN valid FSC
ENTERPRISES MEDICAL CO., LTD. Sizes: 14Fr, 16Fr, 18Fr, 20Fr, 22Fr,
Plot No. 331-C, Building 1, No. 222, Xindu Road, 24Fr, 26Fr, 28Fr, 30Fr
Block 3, Chengjiao Street, Conghua District,
DMCH Society, Guangzhou City, Guangdong Class B
Alamgir Road, Province, 510920, P.R. China Shelf life: 05 years
Karachi FSC China:
(ELI-00252) Validity: 21-10-2026 EC Certificate validity:
Date of R&I: FSC (RRA) UK 26-05-2024
23-12-2024 Validity: 30-06-2029
Fee details: ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

169. Applicant: (Legal Manufacturer) Promed 3-Way Silicon Urethral Approved subject to
M/S Name: Catheter fee verification and
MEDICHEM M/S GUANGDONG ECAN valid FSC
ENTERPRISES MEDICAL CO., LTD. Sizes: 14Fr, 16Fr, 18Fr, 20Fr, 22Fr,

Decisions of 85th Meeting of MDB (21-03-2025) Page 84 of 138

 Plot No. 331-C, Building 1, No. 222, Xindu Road, 24Fr, 26Fr, 28Fr, 30Fr
Block 3, Chengjiao Street, Conghua District,
DMCH Society, Guangzhou City, Guangdong Class B
Alamgir Road, Province, 510920, P.R. China Shelf life: 05 years
Karachi FSC China:
(ELI-00252) Validity: 21-10-2026 EC Certificate validity:
Date of R&I: FSC (RRA) UK 26-05-2024
23-12-2024 Validity: 30-06-2029
Fee details: ISO 13485 Certificate validity: 31-
07-2025
Letter of authorization:
26-06-2028

170. Applicant: (Legal Manufacturer) Promed Drainage Tube Approved subject to

M/S Name: Sizes: fee verification and
MEDICHEM M/S NINGBO LUKE MEDICAL 100% Silicon Round Perforated valid FSC
ENTERPRISES CO., LTD. Drainage Tube:
Plot No. 331-C, Gujiayan, Yangming Road 315400
Block 3, Yuyao City, Zhejiang Province, Sizes: 10Fr, 12 Fr, 14 Fr, 16 Fr, 18
DMCH Society, People’s Republic of China Fr, 20 Fr, 22 Fr, 24 Fr
Alamgir Road, FSC China:
Karachi Validity: 16-08-2026 100% Silicon Flat Perforated
(ELI-00252) FSC (RRA) Germany Drainage Tube:
Date of R&I: submitted
30-12-2024 Sizes:
• 7mm × 15 Fr, (3/4th part
Fee details: perforated)
• 10mm × 15 Fr, (3/4th part
perforated)
• 4mm × 10 Fr, (Full perforated)
• 7mm × 15 Fr, (Full perforated)
• 10mm × 15 Fr, (Full perforated)
• 13mm × 15 Fr (Full perforated)

Class B
Shelf life: 05 years

EC Certificate validity:
26-05-2024

ISO 13485 Certificate validity: 03-

10-2026
Letter of authorization:
26-06-2028

171. Applicant: (Legal Manufacturer) GOBON Approved

M/s MH Name: SINGLE-USE STERILE RUBBER
Pharma M/S Guilin Zizhu Latex Co., Ltd.. SURGICAL GLOVES
Flat No. 1118, Address: No.6 Wushan Road, Sizes, S,M,L XL
11th Floor, Guilin, China. Class B
Eden Heights, 6 Shelf life: 04 years
Main FSC China:
Gulberg,Jail Validity: 19-01-2025 EC Certificate validity:
Road, Lahore 26-05-2024
(ELI-00720)
Date of R&I: ISO 13485 Certificate validity: 03-
24/01/2024 10-2026
Letter of authorization:
Fee details: 23-10-2026

Decisions of 85th Meeting of MDB (21-03-2025) Page 85 of 138

 PKR 25000/-
Slip#
9524409940
Dated
16/11/2023

172. Applicant: (Legal Manufacturer) Ayset® Approved

M/s Moon Name: PET EDTА (K2, KЗ)
Enterprises M/S AYSET TIBBİ ÜRÜNLER VE (Vacuum Blood Collection Tube)
5/6 Rabani PLASTİK Class A
Road , Old ELEKTRONİK GIDA TEMİZLİK Shelf life: 02 years
Anarkali MADDELERİ SAN. A.Ş
Lahore Sarıhamzalı Mah. 47007 Sk Letter of authorization:
(ELI-00356) No:36/A Seyhan Turkey. 16/Oct/2027
Date of R&I:
07/06/2023 FSC China: submitted

Fee details:
PKR 5000/-
Slip#
06807696761
Dated: 25-05-
2023

173. M/s Biologic Legal Manufacturer: HUNTLEIGH Vascular Doppler - Approved

Medical Sytems Name: DMX
Karachi. M/s HUNTLEIGH HEALTH
CARE Ltd. located at Address: 35 Class: B
(ELI-00346) Portman moor Road, Cardiff CF24
D.O.I: 04-05- 5HN United Kingdom MD group: Kit
2024
FSC Validity Shelf life:
Dy. No.: (country of origin):UK For assay: 5 Years
DRAP (R&I) 18-06-2024

Dated: 03-05- ISO 13485 Certificate validity: 16-

2024 12-2027 Storage condition:
2 – 43OC
Fee Challan EC Certificate validity:
No.: 10-01-2026
61173237210
PKR: 25000/- LOA Validity:
30-05-2028
Dated: 03-05-
2024

174. M/s Biologic Legal Manufacturer: HUNTLEIGH Fetal Doppler SR-3 Approved
Medical Sytems Name: Class: B
Karachi. M/s HUNTLEIGH HEALTH MD group: Kit
CARE Ltd. located at Address: 35
(ELI-00346) Portman moor Road, Cardiff CF24 Shelf life:
D.O.I: 04-05- 5HN United Kingdom For assay: 5 Years
2024 Storage condition: 2 – 43OC
Dy. No.: FSC Validity
DRAP (R&I) (country of origin):UK
Dated:03-05- 18-06-2024
2024
Fee Challan ISO 13485 Certificate validity: 16-
No.: 12-2027

Decisions of 85th Meeting of MDB (21-03-2025) Page 86 of 138

 61173237210
PKR: 25000/- EC Certificate validity:
Dated:03-05- 10-01-2026
2024
LOA Validity:
30-05-2028

175. M/s Biologic Legal Manufacturer: HUNTLEIGH TEAM3A FETAL Approved

Medical Sytems Name: Monitor NSB
Karachi. M/s HUNTLEIGH HEALTH Class: B
CARE Ltd. located at Address: 35 MD group: Kit
(ELI-00346) Portman moor Road, Cardiff CF24 Shelf life:
D.O.I: 04-05- 5HN United Kingdom For assay: 5 Year
2024
Dy. No.: FSC Validity Storage condition: 2 – 43OC
DRAP (R&I) (country of origin):UK
Dated:03-05- 18-06-2024
2024
Fee Challan ISO 13485 Certificate validity: 16-
No.: 12-2027

PKR: 25000/- EC Certificate validity:

Dated:03-05- 10-01-2026
2024
LOA Validity:
30-05-2028

176. M/s Biologic Legal Manufacturer: Medi-Care OTOCOMPACT Approved

Medical Solutions S R L Legal office VIA PROFESSIONAL TYPE 11
Systems della Zecca Nr. 1 40121 Bologna
Karachi. BO Facility (Production Site and Class: B
offices) Via P.Nenni NR.3 40026 MD group: System
(ELI-00346) Imola BO Italy Shelf life:
D.O.I: 04-05- Name: For assay: 7 Years
2024 M/s EuroClinic Medi-Care For controls: 7 Years
Dy. No.: Solutions S.r.l, Italy Storage condition: 2 – 43OC
DRAP (R&I) LOA Validity:
Dated:03-05- 31-12-2025 Until further notice.
2024 FSC Validity
Fee Chillan (country of origin):
No.: 09-02-2023
61173237210 EC Certificate validity:
PKR: 25000/- 12-07-2022
Dated:02-05- ISO 13485 Certificate validity: 15-
2024 11-2026

177. M/s Biologic Legal Manufacturer: Medi-Care OTOCOMPACT STEEL TYPE Approved
Medical Sytems Solutions S R L Legal office VIA 11
Karachi. della Zecca Nr. 1 40121 Bologna
BO Facility (Production Site and Class: B
(ELI-00346) offices) Via P.Nenni NR.3 40026 MD group: System
D.O.I: 04-05- Imola BO Italy Shelf life:
2024 Name: For assay: 7 Years
Dy. No.: M/s EuroClinic Medi-Care For controls: 7 Years
DRAP (R&I) Solutions S.r.l, Italy Storage condition: 2 – 43OC
Dated:03-05- LOA Validity:

Decisions of 85th Meeting of MDB (21-03-2025) Page 87 of 138

 2024 31-12-2025 Until further notice.
Fee Challan FSC Validity
No.: (country of origin):
0740001208 09-02-2023
PKR: 25000/- EC Certificate validity:
Dated:03-05- 12-07-2022
2024 ISO 13485 Certificate validity: 15-
11-2026
178. M/s Biologic Legal SEEGEN DISPOSABLE Approved subject to
Medical Sytems Manufacturer: ELECTRONIC FXIBLE submission of valid
Karachi. Name: CHOLEDOCHOSCOPE TYPE and legalized free
M/s Shanghai 11 sale certificate.
(ELI-00346) Seegen
D.O.I: 04-05- Photoelectric Class: B
2024 Technology
Co.,Ltd.,China MD group: Kit
Dy. No.:
DRAP (R&I) Manufacturer Shelf life: For assay:
Dated:03-05- Address: Floor 24 months
2024 3,Building 1,No
4299 jindu Road Minghang Dist., For controls: 24 months
Fee Challan China.
No.: Storage condition: 2 – 40°
394185381 LOA issued on: 29-03-2023
PKR: 25000/
FSC Validity (country of origin):
Dated:03-05- 21-01-2022
2024
EC
Certificate validity: 26-05-
2024

ISO 13485
Certificate validity: 05-03-2026
179. M/s Biologic Legal SEEGEN IMAGING Approved subject to
Medical Sytems Manufacturer: PROCESSOR SYSTEM submission of valid
Karachi. Name: (INCLUDING LIGTH and legalized free
(ELI-00346) M/s Shanghai SOURCE)TYPE 11 sale certificate.
D.O.I: 04-05- Seegen Class: B
2024 Photoelectric
Technology MD group: Kit
Dy. No.: Co.,Ltd.,China
DRAP (R&I) Shelf life: For assay:
Dated:03-05- Manufacturer 24 months
2024 Address: Floor
3,Building 1,No For controls: 24 months
Fee Challan 4299 jindu Road Minghang Dist.,
No.: China. Storage condition: 2 – 40
394185381
PKR: LOA issued on: 29-03-2023
25000/
FSC Validity (country of origin):
Dated:03-05- 21-01-2022
2024
EC
Certificate validity: 26-05-
2024

ISO 13485

Decisions of 85th Meeting of MDB (21-03-2025) Page 88 of 138

 Certificate validity: 05-03-2026
180. M/s Biologic Legal SeeGen Disposable Approved subject to
Medical Sytems Manufacturer: Electronic Flexible submission of valid
Karachi. Name: CystoUreteroscope System and legalized free
(ELI-00346) M/s Shanghai sale certificate.
D.O.I: 04-05- Seegen
2024 Photoelectric
Technology Class: B
Dy. No.: Co.,Ltd.,China
DRAP (R&I) MD group: Kit
Dated:03-05- Manufacturer
2024 Address: Floor Shelf life: For assay:
3,Building 1,No 24 months
Fee Challan 4299 jindu Road Minghang Dist.,
No.: China. For controls: 24 months
394185381
PKR:25000/ LOA issued on: 29-03-2023 Storage condition: 2 – 40°

Dated:03-05- FSC Validity (country of origin):

2024 21-01-2022

EC
Certificate validity: 26-05-
2024

ISO 13485
Certificate validity: 05-03-2026
181. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
M/s. ConvaTec Limited. Surfit Plus
M/s. Muller & Stomahesive Wafer
Phipps, Uzma First Avenue Deeside
Court, Main Industrial Park Deeside, Class A
Clifton Road Flintshire, CH5 2NU, UK.
Karachi. Shelf life:
Manufacturing Site(s): 5 years
ELI-00030 ConvaTec Dominican
RePublic, Inc. Carretera Sanchez, Codes/Sizes (if any):
R&I Details Km. 18.5, Parque Industrial ltabo, 38MM- 125143
19/06/2020 S.A. Dominican Republic. 45MM-125144
57MM-125145
Fee Details. FSC Validity: N/A 70MM-400949
Fee Challan No.
0808821. LOA Validity:
Paid Fee. 5000 28/01/202.
dated 03-06-
2020

Tracking ID
2X5-SR2-
8DPH

182. Applicant Name of Manufacturer: Brand Name: Approved subject to

Name: submission of shelf
M/s. Gimmi GmbH Gimmi Surgical Instruments life, codes and
M/s. Radiant instruments
Medical Address: Class B involved/applied.
Private Gimmi GmbH
Limited. Carl-Zeiss-Str. 6 Shelf life:

Decisions of 85th Meeting of MDB (21-03-2025) Page 89 of 138

 Address : 78532 Tuttlingen
06‐Sher Shah Germany
Block New Tel: +49 (7461) 96590 0
Garden Town Fax: +49 (7461) 9659033
Lahore, www.gimmi.de
Pakistan
FSC:
ELI-000135 Germany, Valid FSC

R&I Details Marketing Authorization Letter

10/05/2024 (LOA):
Valid till: 31/12/2025
Fee Details.
Fee Challan No. Production Quality Management
358853565105 System Certificate (ISO 13485)
Paid Fee. 25000 TUV DAkkS ISO 13485 certificate
dated 03-04- Valid till 31/05/2027
2024
EU Quality Management System
Tracking ID Certificate (MDR):
VY9-NDU- TÜV SÜD Product Service GmbH
XQ67 valid along with extension letter
valid
31 December 2028
183. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG Holding Micropipettes of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Holding Certificate.
Ltd. Micropipettes
Address: Plot FSC: Ref no. Product Description Firm shall submit the
No. FD-35-36- Germany differential fee for
HP-80- Haltepipette-OD:80µm, BA:0°
A7, National Dated: 24.02.2021 Class B, as per
0°
Industrial Park, DRAP fee schedule
HP-80- Haltepipette-OD:80µm, BA:20°
Korangi Creek, EC Certificate: notified in SRO-
20°
Karachi. Valid From: 28.07.2019 1324, Dated 30th
Valid till: 27.05.2024 HP-80- Haltepipette-OD:80µm, BA:30°
August 2024.
(License No. 30°
ELI-00402) Letter of Authorization: HP-80- Haltepipette-OD:80µm, BA:35°
Dated: 24.10.2019 35°
R&I Date: HP-80- Haltepipette-OD:80µm, BA:40°
18.02.2020 ISO Certificate: 40°
Effective Date: 12.03.2021 HP- Haltepipette-OD:100µm, BA:0°
Fee details: Expiry Date: 27.07.2022 100-0°
Amount Paid: HP- Haltepipette-OD:100µm, BA:20°
5,000/‐ 100-20°
Challan no. HP- Haltepipette-OD:100µm, BA:30°
0790298 100-30°
Dated:11.02.20 HP- Haltepipette-OD:100µm, BA:35°
20 100-35°
HP- Haltepipette-OD:100µm, BA:40°
100-40°
HP- Haltepipette-OD:110µm, BA:30°
110-30°
HP- Haltepipette-OD:110µm, BA:35°
110-35°
HP- Haltepipette-OD:120µm, BA:0°
120-0°
HP- Haltepipette-OD:120µm, BA:20°

Decisions of 85th Meeting of MDB (21-03-2025) Page 90 of 138

 120-20°
HP- Haltepipette-OD:110µm, BA:30°
120-30°
HP- Haltepipette-OD:120µm, BA:35°
120-35°
HP- Haltepipette-OD:120µm, BA:40°
120-40°

Code: 001
MD Group: Single
Class: B

Declaration of Conformity
Issuance date: 15.03.2021

Shelf Life: 3 Years

Storage Condition: Store at room

temperature below 30°C
184. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG DENU – Tips of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: DENU – Tips Certificate.
Ltd.
Address: Plot FSC: Article no. Product list Firm shall submit the
No. FD-35-36- Germany differential fee for
GY-080/1 Denu-Tip 80µm; 10 tips per vial
A7, National Dated: 24.02.2021 Class B, as per
Industrial Park, GY-100/1 Denu-Tip 100µm; 10 tips per fee schedule
DRAP
Korangi Creek, EC Certificate: vial notified in SRO-
Karachi. Valid From: 28.07.2019 GY-125/1 1324,
Denu-Tip 125µm; 10 tips perDated 30th
Valid till: 27.05.2024 vial August 2024.
(License No. GY-130/1 Denu-Tip 130µm; 10 tips per
ELI-00402) Letter of Authorization: vial
Dated: 24.10.2019 GY-135/1 Denu-Tip 135µm; 10 tips per
R&I vial
Date:18.02.202 ISO Certificate: GY-140/1 Denu-Tip 140µm; 10 tips per
0 Effective Date: 12.03.2021 vial
Expiry Date: 27.07.2022 GY-145/1 Denu-Tip 145µm; 10 tips per
Fee details: vial
Amount Paid: GY-150/1 Denu-Tip 150µm; 10 tips per
5,000/‐ vial
Challan no. GY-155/1 Denu-Tip 155µm; 10 tips per
0790339 vial
Dated:11.02.20 GY-165/1 Denu-Tip 165µm; 10 tips per
20 vial
GY-170/1 Denu-Tip 170µm; 10 tips per
vial
GY-175/1 Denu-Tip 175µm; 10 tips per
vial
GY-200/1 Denu-Tip 200µm; 10 tips per
vial
GY-275/1 Denu-Tip 275µm; 10 tips per
vial
GY-300/1 Denu-Tip 300µm; 10 tips per
vial
GY-550/1 Denu-Tip 550µm; 10 tips per
vial

Decisions of 85th Meeting of MDB (21-03-2025) Page 91 of 138

 GY- Denu-Tip 80µm; 20 tips per vial
080/20
GY- Denu-Tip 100µm; 20 tips per
100/20 vial
GY- Denu-Tip 125µm; 20 tips per
125/20 vial
GY- Denu-Tip 130µm; 20 tips per
130/20 vial
GY- Denu-Tip 135µm; 20 tips per
135/20 vial
GY- Denu-Tip 140µm; 20 tips per
140/20 vial
GY- Denu-Tip 145µm; 20 tips per
145/20 vial
GY- Denu-Tip 150µm; 20 tips per
150/20 vial
GY- Denu-Tip 155µm; 20 tips per
155/20 vial
GY- Denu-Tip 165µm; 20 tips per
165/20 vial
GY- Denu-Tip 170µm; 20 tips per
170/20 vial
GY- Denu-Tip 175µm; 20 tips per
175/20 vial
GY- Denu-Tip 200µm; 20 tips per
200/20 vial
GY- Denu-Tip 275µm; 20 tips per
275/20 vial
GY- Denu-Tip 300µm; 20 tips per
300/20 vial
GY- Denu-Tip 550µm; 20 tips per
550/20 vial
GY-080/5 Denu-Tip 80µm; 5 tips per vial
GY-100/5 Denu-Tip 100µm; 5 tips per vial
GY-125/5 Denu-Tip 125µm; 5 tips per vial
GY-130/5 Denu-Tip 130µm; 5 tips per vial
GY-135/5 Denu-Tip 135µm; 5 tips per vial
GY-140/5 Denu-Tip 140µm; 5 tips per vial
GY-145/5 Denu-Tip 145µm; 5 tips per vial
GY-150/5 Denu-Tip 150µm; 5 tips per vial
GY-155/5 Denu-Tip 155µm; 5 tips per vial
GY-165/5 Denu-Tip 165µm; 5 tips per vial
GY-170/5 Denu-Tip 170µm; 5 tips per vial
GY-175/5 Denu-Tip 175µm; 5 tips per vial
GY-200/5 Denu-Tip 200µm; 5 tips per vial
GY-275/5 Denu-Tip 275µm; 5 tips per vial
GY-300/5 Denu-Tip 300µm; 5 tips per vial
GY-550/5 Denu-Tip 550µm; 5 tips per vial

Code: GY
MD Group: Single
Class: B

Declaration of Conformity
Issuance date: 15.03.2021

Shelf Life: 3 Years

Decisions of 85th Meeting of MDB (21-03-2025) Page 92 of 138

 Storage Condition: Store at room
temperature below 30°C
185. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG Denuding Micropipettes of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Certificate.
Ltd. Denuding Micropipettes
Address: Plot FSC: Firm shall submit the
No. FD-35-36- Germany Code: 005 differential fee for
A7, National Dated: 24.02.2021 MD Group: Single Class B, as per
Industrial Park, Class: B DRAP fee schedule
Korangi Creek, EC Certificate: notified in SRO-
Karachi. Valid From: 28.07.2019 Shelf Life: 3 years 1324, Dated 30th
Valid till: 27.05.2024 August 2024.
(License No. Storage Condition: Store at room
ELI-00402) Letter of Authorization: temperature below 30°C
Dated: 24.10.2019
R&I Date:
18.02.2020 ISO Certificate:
Effective Date: 12.03.2021
Fee details: Expiry Date: 27.07.2022
Amount Paid:
5,000/‐
Challan no.
0790338
Dated:11.02.20
20
186. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG Biopsy Pipettes of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Certificate.
Ltd. Biopsy Pipettes
Address: Plot Ref No. Product description Firm shall submit the
No. FD-35-36- FSC: BP-10-0O- differential fee for
Blastomere Biopsie-Pipette-ID:10
A7, National Germany bl µm, BA:0o, blunt Class B, as per
Industrial Park, Dated: 24.02.2021 BP-10-0O- DRAP fee schedule
Blastomere Biopsie-Pipette-ID:10
Korangi Creek, be µm, BA:0 , bevelled notified in SRO-
o

Karachi. EC Certificate: O 1324, Dated 30th

BP-10-30 - Blastomere Biopsie-Pipette-ID:10
Valid From: 28.07.2019 bl o
µm, BA:30 , blunt August 2024.
(License No. Valid till: 27.05.2024 O
BP-10-30 - Blastomere Biopsie-Pipette-ID:10
ELI-00402) be µm, BA:30o, bevelled
Letter of Authorization: BP-10-35O- Blastomere Biopsie-Pipette-ID:10
R&I Date: Dated: 24.10.2019 bl µm, BA:35o, blunt
18.02.2020 O
BP-10-35 - Blastomere Biopsie-Pipette-ID:10
ISO Certificate: be µm, BA:35o, bevelled
Fee details: Effective Date: 2021.03.12 O
BP-15-0 - Blastomere Biopsie-Pipette-ID:15
Amount Paid: Expiry Date: 2022.07.27 bl µm, BA:0o, blunt
5,000/‐ O
BP-15-0 - Blastomere Biopsie-Pipette-ID:15
Challan no. be µm, BA:0o, bevelled
0790337 O
BP-15-30 - Blastomere Biopsie-Pipette-ID:15
Dated:11.02.20
bl µm, BA:30o, blunt
20 O
BP-15-30 - Blastomere Biopsie-Pipette-ID:15
be µm, BA:30o, bevelled
O
BP-15-35 - Blastomere Biopsie-Pipette-ID:15
bl µm, BA:35o, blunt

Decisions of 85th Meeting of MDB (21-03-2025) Page 93 of 138

 BP-15-35O- Blastomere Biopsie-Pipette-ID:15
be µm, BA:35o, bevelled
BP-20-0O- Blastomere Biopsie-Pipette-ID:20
bl µm, BA:0o, blunt
BP-20-0O- Blastomere Biopsie-Pipette-ID:20
be µm, BA:0o, bevelled
BP-20-30O- Blastomere Biopsie-Pipette-ID:20
bl µm, BA:30o, blunt
BP-20-30O- Blastomere Biopsie-Pipette-ID:20
be µm, BA:30o, bevelled
BP-20-35O- Blastomere Biopsie-Pipette-ID:20
bl µm, BA:35o, blunt
BP-20-35O- Blastomere Biopsie-Pipette-ID:20
be µm, BA:35o, bevelled
BP-25-0O- Blastomere Biopsie-Pipette-ID:25
bl µm, BA:0o, blunt
BP-25-0O- Blastomere Biopsie-Pipette-ID:25
be µm, BA:0o, bevelled
BP-25-30O- Blastomere Biopsie-Pipette-ID:25
bl µm, BA:30o, blunt
BP-25-30O- Blastomere Biopsie-Pipette-ID:25
be µm, BA:30o, bevelled
BP-30-0O- Blastomere Biopsie-Pipette-ID:30
bl µm, BA:0o, blunt
BP-30-0O- Blastomere Biopsie-Pipette-ID:30
be µm, BA:0o, bevelled
BP-30-30O- Blastomere Biopsie-Pipette-ID:30
bl µm, BA:30o, blunt
BP-30-30O- Blastomere Biopsie-Pipette-
be ID:30µm, BA:30o, bevelled
BP-30-35O- Blastomere Biopsie-Pipette-ID:30
bl µm, BA:35o, blunt
BP-30-35O- Blastomere Biopsie-Pipette-
be ID:30µm, BA:35o, bevelled
BP-35-0O- Blastomere Biopsie-Pipette-ID:35
bl µm, BA:0o, blunt
BP-35-0O- Blastomere Biopsie-Pipette-ID:35
be µm, BA:0o, bevelled
BP-35-30O- Blastomere Biopsie-Pipette-ID:35
bl µm, BA:30o, blunt
BP-35-30O- Blastomere Biopsie-Pipette-ID:35
be µm, BA:30o, bevelled
BP-35-35O- Blastomere Biopsie-Pipette-ID:35
bl µm, BA:35o, blunt
BP-35-35O- Blastomere Biopsie-Pipette-ID:35
be µm, BA:35o, bevelled

Code: 004
MD Group: Single
Class: B

Declaration of Conformity
Issuance date: 15.03.2021

Shelf Life: 3 Years

Storage Condition: Store at room

temperature below 30°C

Decisions of 85th Meeting of MDB (21-03-2025) Page 94 of 138

187. Applicant Name of Manufacturer: Brand Name: Culture Approved,
Name: Generic Name: Subject to submission
Gynemed GmbH & Co. KG 1. GM501 Mineral Oil of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 4 MO 0100 - 1 x 100 m LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. 4 MO 0500 - 1 x 500 ml Certificate.
Ltd.
Address: Plot FSC: Code: GM501 Firm shall submit the
No. FD-35-36- Germany MG Group: Cluster differential fee for
A7, National Dated: 24.02.2021 Class: B Class B, as per
Industrial Park, Models: DRAP fee schedule
Korangi Creek, EC Certificate: •GM501 Mineral oil notified in SRO-
Karachi. Valid from: 28.07.2019 1324, Dated 30th
Valid till: 27.05.2024 Declaration of Conformity August 2024.
(License No. Issuance date: 15.03.2021
ELI-00402) Letter of Authorization:
Dated: 24.10.2019 Shelf Life:
R&I Date:
18.02.2020 •GM501 Mineral oil – 18 Months
ISO Certificate:
Fee details: Effective Date: 2021.03.12 Storage Condition:
Amount Paid: Expiry Date: 2022.07.27 GM501 Mineral oil – Store at 15 –
5,000/‐ 25o C.
Challan no.
0790293
Dated:
11.02.2020
188. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG Injection Micropipettes of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Certificate.
Ltd. Injection Micropipettes
Address: Plot FSC: Ref No. Product description Firm shall submit the
No. FD-35-36- Germany IC-5-0o - ICSI-Pipette – ID: 5µm, differential
BA: 0O, fee for
A7, National Dated: 24.02.2021 be Bevelled Class B, as per
Industrial Park, IC-5-0o -s ICSI-Pipette – ID: 5µm, DRAP
BA: 0Ofee
, schedule
Korangi Creek, EC Certificate: with spike notified in SRO-
Karachi. Valid from: 28.07.2019 IC-5-20o - ICSI-Pipette – ID: 5µm, 1324,
BA: 20 Dated
O
, 30th
Valid till: 27.05.2024 be Bevelled August 2024.
(License No. IC-5-20o - ICSI-Pipette – ID: 5µm, BA: 20O,
ELI-00402) Letter of Authorization: s with spike
Dated: 24.10.2019 IC-5-30o - ICSI-Pipette – ID: 5µm, BA: 30O,
R&I Date: be Bevelled
18.02.2020 ISO Certificate: IC-5-30o - ICSI-Pipette – ID: 5µm, BA: 30O,
Effective Date: 2021.03.12 s with spike
Fee details: Expiry Date: 2022.07.27 IC-5-35o - ICSI-Pipette – ID: 5µm, BA: 35O,
Amount Paid: be Bevelled
5,000/‐ IC-5-35o - ICSI-Pipette – ID: 5µm, BA: 35O,
Challan no. s with spike
0790299 IC-5-40o - ICSI-Pipette – ID: 5µm, BA: 40O,
Dated: be Bevelled
11.02.2020
IC-5-40o - ICSI-Pipette – ID: 5µm, BA: 40O,
s with spike
IC-7-0o - ICSI-Pipette – ID: 7µm, BA: 0O,
be Bevelled
IC-7-0o -s ICSI-Pipette – ID: 7µm, BA: 0O,
with spike
IC-7-20o - ICSI-Pipette – ID: 7µm, BA: 20O,

Decisions of 85th Meeting of MDB (21-03-2025) Page 95 of 138

 be Bevelled
IC-7-20o - ICSI-Pipette – ID: 5µm, BA: 20O,
s with spike
IC-7-30o - ICSI-Pipette – ID: 7µm, BA: 30O,
be Bevelled
IC-7-30o - ICSI-Pipette – ID: 7µm, BA: 30O,
s with spike
IC-7-35o - ICSI-Pipette – ID: 7µm, BA: 35O,
be Bevelled
IC-7-35o - ICSI-Pipette – ID: 7µm, BA: 35O,
s with spike
IC-7-40o - ICSI-Pipette – ID: 7µm, BA: 40O,
be Bevelled
IC-7-40o - ICSI-Pipette – ID: 7µm, BA: 40O,
s with spike
IC-SL- ICSI-Pipette 30o mit Spike, ID: 4.6
4.6-30o-s µm thin line
IC-SL- ICSI-Pipette 35o mit Spike, ID: 4.6
4.6-35o-s µm thin line

Code: 002
MD Group: Single
Class: B
Shelf Life: 3 Years

Declaration of Conformity
Issuance date: 15.03.2021

Storage Condition: Store at room

temperature below 30°C
189. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Gynemed GmbH & Co. KG Hatching Micropipettes of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Certificate.
Ltd. Hatching Micropipettes
Address: Plot FSC: Firm shall submit the
No. FD-35-36- Germany Model Code: differential fee for
A7, National Dated: 24.02.2021 Code Angle Class B, as per
Taper
Industrial Park, 003 20°, 30°, 35° or DRAP
short (S) fee schedule
Korangi Creek, EC Certificate: straight notified in SRO-
Karachi. Valid from: 28.07.2019 1324, Dated 30th
Valid till: 27.05.2024 003 20°, 30°, 35° or Long (L) 2024.
August
(License No. Letter of Authorization: straight
ELI-00402) Dated: 24.10.2019
MD Group: Single
R&I Date: ISO Certificate: Class: B
18.02.2020 Effective Date: 2021.03.12
Expiry Date: 2022.07.27 Shelf Life: 3 Years

Fee details: Storage Condition: Store at room

Amount Paid: temperature below 30°C
5,000/‐
Challan no.
0790300
Dated:

Decisions of 85th Meeting of MDB (21-03-2025) Page 96 of 138

 11.02.2020

190. Applicant Name of Manufacturer: Brand Name: Approved,

Name: Subject to submission
Gynemed GmbH & Co. KG GM501 SpermMobil of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Generic Name: Certificate.
Ltd. GM501 SpermMobil
Address: Plot FSC:
No. FD-35-36- Germany Code:
A7, National Dated: 05.08.2019 1. GM501 SpermMobil
Industrial Park, 4 GM 501SMOBIL5 - 1 x
Korangi Creek, EC Certificate: 5 ml
Karachi. Effective Date: 28.07.2019 4 GM 501SMOBIL5-S -
Expiry Date: 27.05.2024 1 x 1 ml
(License No. MD Group: Cluster
ELI-00402) Letter of Authorization: Class: A
Dated: 24.10.2019
R&I Date: Declaration of Conformity
22.02.2021 ISO Certificate: Issuance date: 15.03.2021
Effective Date: 2021.03.12
Fee details: Expiry Date: 2022.07.27 Shelf Life: 6 Months
Amount Paid: Storage Condition: Store at 2‐8oC.
5,000/‐
Challan no.
1979355

191. Applicant Name of Manufacturer: Brand Name: Approved,

Name: Subject to submission
Gynemed GmbH & Co. KG GM508 CultActive of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 Generic Name: GM508 LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. CultActive Certificate.
Ltd.
Address: Plot FSC: Model Code: 4 GM 508CULT-
No. FD-35-36- Germany active1 1 x 1ml
A7, National Dated: 05.08.2019
Industrial Park, MD Group: Cluster
Korangi Creek, EC Certificate: Class: A
Karachi. Valid from: 28.07.2019
Valid till: 27.05.2024 Declaration of Conformity
(License No. Issuance date: 15.03.2021
ELI-00402) Letter of Authorization:
Dated: 24.10.2019 Shelf Life: 6 Months
R&I Date: Storage Condition: Store at 2‐8oC.
22.02.2021 ISO Certificate:
Effective Date: 2021.03.12
Fee details: Expiry Date: 2022.07.27
Amount Paid:
5,000/‐
Challan no.
1979355

192. Applicant Name of Manufacturer: Brand Name: Approved,

Name: Subject to submission
Gynemed GmbH & Co. KG Oocyte Aspiration Needles of valid copy of
M/s. Galaxy Address: Lubecker Str. 9 23738 Generic Name: Oocyte Aspiration LOA, FSC, EC, ISO
Pharma Pvt. Lensahn Germany. Needles Certificate.
Ltd.

Decisions of 85th Meeting of MDB (21-03-2025) Page 97 of 138

 Address: Plot FSC: Class: B Firm shall submit the
No. FD-35-36- Germany MD Group: Cluster differential fee for
A7, National Dated: 05.08.2019 Class B, as per
Industrial Park, Model code and specification: DRAP fee schedule
Korangi Creek, • GY-711724LF single lumen, notified in SRO-
Karachi. EC Certificate: without flushing, 17‐gauge needle, 1324, Dated 30th
Valid from: 28.07.2019 length of the needle 32 cm, back cut August 2024.
(License No. Valid till: 27.05.2024 bevel, echo mark micro blasting,
ELI-00402) length of aspiration tubing 100 cm,
Letter of Authorization: length of vacuum tubing 100 cm,
• GY- Dated: 24.10.2019 luer female
711724LF • GY-711724LF-A single lumen,
R&I Date: ISO Certificate: without flushing, 17‐gauge needle,
15.03.2021 Effective Date: 2021.03.12 length of the needle 35 cm, back cut
Fee Details: Expiry Date: 2022.07.27 bevel, echo mark micro blasting,
Amount Paid: length of aspiration tubing 100 cm,
5,000/‐ length of vacuum tubing 100 cm,
Challan no. luer female
2072927 • GY-711824LF single lumen,
Dated: without flushing, 18‐gauge needle,
11.03.2021 length of the needle 32 cm, back cut
bevel, echo mark micro blasting,
• GY- length of aspiration tubing 100 cm,
711724LF-A length of vacuum tubing 100 cm,
R&I Date: luer female
15.03.2021 • GY-721724LF single lumen, with
flushing, 17‐gauge needle, length of
the needle 32 cm, back cut bevel,
Fee details: echo mark micro blasting, length of
Amount Paid: aspiration tubing 100 cm, length of
5,000/‐ vacuum tubing 100 cm, luer female
Challan no. • GY-931627LF-A double lumen,
2072928 with flushing, outer diameter 16‐
Dated: gauge needle, length of the needle
11.03.2021 35 cm, back cut bevel, echo mark
dots up to the end of the tips, length
• GY- of aspiration tubing 100 cm, length
711824LF of vacuum tubing 100 cm, luer
R&I Date: female.
15.03.2021
Declaration of Conformity
Fee details: Issuance date: 15.03.2021
Amount Paid:
5,000/‐ Shelf Life: 3 Years
Challan no.
2072926 Storage Condition: Store at room
Dated: temperature below 30°C
11.03.2021

• GY-
721724LF
R&I date:
15.03.2021

Fee details:
Amount Paid:
5,000/‐
Challan no.
2072925

Decisions of 85th Meeting of MDB (21-03-2025) Page 98 of 138

 Dated:
11.03.2021

• GY-
931627LF-A
R&I Date:
15.03.2021

Fee details:
Amount Paid:
5,000/‐
Challan no.
2072924
Dated:
11.03.2021

193. Applicant Name of Manufacturer: Brand Name: Approved,

Name: Subject to submission
IVF Prime Sağlik Ürünleri San. Ve Embryo Shield of valid copy of
M/s. Galaxy Ticaret. A.Ş. LOA, FSC, EC, ISO
Pharma Pvt. Generic Name: Certificate.
Ltd. Address: Çamlica Mah. Anadolu Embryo Shield Inline Filter
Address: Plot Blv. N Blok No: 20 N İÇ Kapi No:
No. FD-35-36- 1 Yenimahalle/Ankara/TURKEY Model: ES002
A7, National Sizes:
Industrial Park, Free Sale Certificate Height: 25 cm Diameter: 73mm
Korangi Creek, Date of issue: 24 May 2021
Karachi. Validity: 36 months MD Group: Single use

(Lic No. ELI- ISO 13485 certificate Class-A

00402) Validity: 16-Oct-2023
Declaration of conformity:
R& I Date: Letter of authorization: Issuance date: 03.01.2022
(21/Mar/2023) Dated: 2022-07-18
Shelf Life: The product’s shelf life
Fee details: was identified as 3 years according
Amount paid: to the raw material.
PKR 5,000/-
Paid Slip /
challan No.: Storage conditions: The device has
312194754875 not got any radioactivity property.
Dated: The products are stored at 05- 24 °C
(10/03/2023) and at low humidity (40-60% RH)
before being shipped to the
customer. Excessive storage
conditions such as exposure to
direct sunlight and / or storage on or
near radiators may destroy the
product.
194. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
IVF Prime Sağlik Ürünleri San. Ve Embryo Shield of valid copy of
M/s. Galaxy Ticaret. A.Ş. Generic Name: Embryo Shield LOA, FSC, EC, ISO
Pharma Pvt. Inline Filter Certificate.
Ltd. Address: Çamlica Mah. Anadolu
Address: Plot Blv. N Blok No: 20 N İÇ Kapi No: Model: ES001
No. FD-35-36- 1 Yenimahalle/Ankara/TURKEY Sizes:
A7, National Height: 30 cm Diameter: 73mm
Industrial Park, Free Sale Certificate

Decisions of 85th Meeting of MDB (21-03-2025) Page 99 of 138

 Korangi Creek, Date of issue: 24 May 2021 MD Group: Single use
Karachi. Validity: 36 months
Class-A
(Lic No. ELI- ISO 13485 certificate
00402) Validity: 16-Oct-2023 Declaration of conformity:
Issuance date: 02.01.2023
R& I Date: Letter of authorization:
(21/Mar/2023) Dated: 2022-07-18 Shelf Life: The product’s shelf life
was identified as 3 years according
Fee details: to the raw material.
Amount paid: Storage conditions: The device has
PKR 5,000/- not got any radioactivity property.
Paid Slip / The products are stored at 05- 24 °C
challan No.: and at low humidity (40-60% RH)
4337117616 before being shipped to the
Dated: customer. Excessive storage
(10/03/2023) conditions such as exposure to
direct sunlight and / or storage on or
near radiators may destroy the
product.
195. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
Anhui Deepblue Medical Epithelial Tissue Staining
M/s. Galaxy Technology Co., Ltd. Solution
Pharma Pvt.
Ltd. Address: Generic Name: Epithelial Tissue
Address: Plot 4th Floor D-1 # Zone, Pearl Staining Solution
No. FD-35-36- Industrial Park 106 Innovation
A7, National Avenue, High-Tech Development Product Code: ET2CO-X
Industrial Park, Zone 230088 Hefei, Anhui, China Model: Ordinary/Improved Packing
Korangi Creek, & No. 777 Jimingshan Road, High- Specifications:
Karachi. Tech Development Zone, 230088 1/2/3/5/10/20/50/100 pcs/box or
Hefei, Anhui, China. 3/5/8/10/12/15 ml/bottle
(Lic No. ELI-
00402) FSC: MD Group: Kit
Validity: July 2, 2025 Class: A
R&I Date:
16.08.2024 ISO Certificate: Declaration of Conformity
Valid From: 14.11.2023 Issuance date: 29.06.2023
Fee details: Valid Until: 21.06.2024
Amount Paid: Shelf Life: 24 Months
5,000/‐ EC Certificate: Storage conditions: Sealed and
Challan no. Valid From: 27.06.2023 stored in a ventilated and dry place
6148156532 Valid till: 25.05.2027 at -10 oC to 40oC. After the foil
Dated: pouch is unsealed, the test device
09.05.2024 Letter of Authorization: should be used as soon as possible.
Valid From: May 7, 2024
Valid Until: May 7, 2026
196. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
Anhui Deepblue Medical LH Ovulation Test (Colloidal of valid copy of FSC,
M/s. Galaxy Technology Co., Ltd. Gold) EC, ISO Certificate.
Pharma Pvt. Address: Generic Name: LH Ovulation
Ltd. 4th Floor D-1 # Zone, Pearl Test (Colloidal Gold)
Address: Plot Industrial Park 106 Innovation
No. FD-35-36- Avenue, High-Tech Development
A7, National Zone 230088 Hefei, Anhui, China. Model: Strip/Midstream
Industrial Park, Specifications:
Korangi Creek, FSC: 1 Pcs/bag, 3/5/10/20/50/100 pcs/box

Decisions of 85th Meeting of MDB (21-03-2025) Page 100 of 138

 Karachi. Validity: Sep 4, 2024
MD Group: Kit
(Lic No. ELI- ISO Certificate: Class: B
00402) Valid From: 22.06.2021
Valid Until: 21.06.2024 Declaration of Conformity
R&I Date: Issuance date: 09.01.2019
18.10.2023 EC Certificate:
Valid From: 22.06.2018 Shelf Life: 24 Months
Fee details: Valid Until: 21.06.2023 Storage Condition: The test kit can
Amount Paid: be stored at temperatures between 4
5,000/‐ Letter of Authorization: to 30 oC in the sealed pouch for 24
Challan no. Dated: 18.05.2023 months.
3826481779 Validity: 3 Years Should be Kept away from direct
Dated: sunlight, moisture and heat.
22.05.2023

Additional
Challan:
Amount Paid:
20,000/-
Challan no.
9865525291
Dated:
25.09.2023

197. Applicant Name of Manufacturer: Brand Name: Approved,

Name: Subject to submission
Anhui Deepblue Medical IGFBP-1(PROM) Test Cassette of valid copy of FSC,
M/s. Galaxy Technology Co., Ltd. (Colloidal Gold) EC, ISO Certificate.
Pharma Pvt. Address: Generic Name: IGFBP-1(PROM)
Ltd. 4th Floor D-1 # Zone, Pearl Test Cassette (Colloidal Gold)
Address: Plot Industrial Park 106 Innovation
No. FD-35-36- Avenue, High-Tech Development Model: Strip, cassette:
A7, National Zone 230088 Hefei, Anhui, China. 1/3/5/10/20/50/100 pcs/box
Industrial Park,
Korangi Creek, FSC: MD Group: Kit
Karachi. Validity: March 24, 2024 Class: B

(Lic No. ELI- ISO Certificate: Declaration of Conformity

00402) Valid From: 22.06.2021 Issuance date: 29.07.2020
Valid Until: 21.06.2024
R&I Date: Shelf Life: 24 Months. Use within 1
18.10.2023 EC Certificate: hour after opening.
Valid From: 26.05.2022 Storage conditions: 4 to 30oC,
Fee details: Valid till: 25.05.2027 stored in dark and dry conditions,
Amount Paid: cryopreserved should be avoided.
5,000/‐ Letter of Authorization:
Challan no. Dated: 18.05.2023
42403086334 Validity: 3 Years
Dated:
22.05.2023

Additional
Challan:
Amount Paid:
20,000/-
Challan no.
86392209181
Dated:

Decisions of 85th Meeting of MDB (21-03-2025) Page 101 of 138

 22.09.2023
198. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to submission
INVO Bioscience™ 5582 Broadcast INVOcell™ Culture Device of valid copy of
M/s. Galaxy Court Sarasota, Florida 34240 USA Generic Name: INVOcell™ Culture LOA, FSC, EC, ISO
Pharma Pvt. Device Certificate.
Ltd. Physical Manufacturer:
Address: Plot Contract Manufacturer NextPhase Model: FG-002
No. FD-35-36- Medical Devices LLC 88 Airport Sizes: The retention device comes
A7, National Drive, Rochester, New Hampshire in a single size: 70mm.
Industrial Park, 03867 USA
Korangi Creek, MD Group: Single
Karachi. Free Sale Certificate
Issued by U.S Food and Drug Class-B
(Lic No. ELI- Administration (FDA)
00402) Validity: (30.04.2022) Declaration of conformity:
Issuance date: (13/NOV/2019)
R& I Date: ISO 13485 certificate
(12/April/2021) Validity: 02-04-2023 Shelf Life 6 Years

Fee details: EC Certificate:

Amount paid: Validity: (26.05.2024) Storage conditions: Store at Room
PKR 25,000/- temperature below 25°C (77°F)
Paid Slip / Letter of authorization: away from moisture and direct heat.
challan No.: Validity: 2024-08-07
2072910
Dated:
(12/April/2021)

199. Applicant Name of Manufacturer: Brand Name: Deferred for

Name: submission of DRAP
Brand name LEO LIFE Undis-Catheter Mount R&I receiving and
Total paid bank challan.
Technologies SHAOXING UNDIS Class: B
(Pvt) Ltd. MEDICAL MD group: Single
TECHNOLOGY CO.,
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
5627218377 http://www.undis.cn/
PKR: 31,000/-
LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31

Decisions of 85th Meeting of MDB (21-03-2025) Page 102 of 138

200. Applicant Name of Manufacturer: Brand Name: Deferred for
Name: submission of DRAP
Brand name LEO LIFE Undis-Catheter Mount R&I receiving and
Total paid bank challan.
Technologies SHAOXING UNDIS Class: B
(Pvt) Ltd. MEDICAL MD group: Single
TECHNOLOGY CO.,
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
5627218377 http://www.undis.cn/
PKR: 31,000/-
LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31
201. Applicant Name of Manufacturer: Brand Name: Deferred for
Name: submission of DRAP
Brand name LEO LIFE Undis-Closed Suction R&I receiving and
Total System paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Set
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
9916977914 http://www.undis.cn/
PKR: 31,000/-
LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31

Decisions of 85th Meeting of MDB (21-03-2025) Page 103 of 138

202. Applicant Name of Manufacturer: Brand Name: Deferred for
Name: submission of DRAP
Brand name LEO LIFE Disposable Anesthesia R&I receiving and
Total Breathing Circuit paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Set
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
0339245705 http://www.undis.cn/
PKR: 31,000/-
LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31
203. Applicant Name of Manufacturer: Brand Name: Deferred for
Name: submission of DRAP
Brand name LEO LIFE Disposable Anesthesia R&I receiving and
Total Mask paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Single
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
164878026701 http://www.undis.cn/
PKR: 31,000/-
LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31

Decisions of 85th Meeting of MDB (21-03-2025) Page 104 of 138

204. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Disposable Breathing R&I receiving and
Total Filter paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Single
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
Province, the People's
R&I Dated: Republic of China
09/August/202 Tel: 0086-575-8521 5008
4 Fax: 0086-575-8521 5007
Fee Challan Website:
No: http://www.undis.cn/
7508062254
PKR: 31,000/- LOA Validity:
23/05/2027

FSC Validity:
30/05/2026

DOC Validity:
2028-12-31
205. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Disposble Heated Wire R&I receiving and
Total Circuit paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Set
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
65313147163 http://www.undis.cn/
PKR: 31,000/-
LOA Validity: 23/05/2027

FSC Validity: 30/05/2026

DOC Validity:2028-12-31
206. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Heat And Moisture R&I receiving and
Total Exchanger paid bank challan.

Decisions of 85th Meeting of MDB (21-03-2025) Page 105 of 138

 Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: Single
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
285643559988 http://www.undis.cn/
PKR: 31,000/-
LOA Validity: 23/05/2027

FSC Validity: 30/05/2026

DOC Validity:2028-12-31
207. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE High Flow Nasal R&I receiving and
Total Cannula paid bank challan.
Technologies SHAOXING UNDIS
(Pvt) Ltd. MEDICAL Class: B
TECHNOLOGY CO., MD group: System
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
63631796733 http://www.undis.cn/
PKR: 31,000/-
LOA Validity: 23/05/2027

FSC Validity: 30/05/2026

DOC Validity:2028-12-31
208. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Nasal Oxygen Cannula R&I receiving and
Total paid bank challan.
Technologies SHAOXING UNDIS Class: B
(Pvt) Ltd. MEDICAL MD group: Single
TECHNOLOGY CO.,
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11

Decisions of 85th Meeting of MDB (21-03-2025) Page 106 of 138

 Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:
158351075 http://www.undis.cn/
PKR: 31,000/-
LOA Validity: 23/05/2027

FSC Validity: 30/05/2026

DOC Validity:2028-12-31
209. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Nebulizer Tube R&I receiving and
Total paid bank challan.
Technologies SHAOXING UNDIS Class: B
(Pvt) Ltd. MEDICAL MD group: Set
TECHNOLOGY CO.,
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
Province, the People's
R&I Dated: Republic of China
09/August/202 Tel: 0086-575-8521 5008
4 Fax: 0086-575-8521 5007
Fee Challan Website:
No: http://www.undis.cn/
9677848547
PKR: 31,000/- LOA Validity: 23/05/2027
FSC Validity: 30/05/2026

DOC Validity:2028-12-31
210. Applicant Name of Manufacturer: Brand Name: Deffered for
Name: submition of DRAP
Brand name LEO LIFE Oxygen Mask R&I receiving and
Total paid bank challan.
Technologies SHAOXING UNDIS Class: B
(Pvt) Ltd. MEDICAL MD group: Set
TECHNOLOGY CO.,
696, J-2 Johar LTD
Town, District
Lahore, No.12 Yuexing
Pakistan Technology Park, No.11
Fanrong Road, Binhai
(ELI- 00129). New Area,312366
Shaoxing, Zhejiang
R&I Dated: Province, the People's
09/August/202 Republic of China
4 Tel: 0086-575-8521 5008
Fee Challan Fax: 0086-575-8521 5007
No: Website:

Decisions of 85th Meeting of MDB (21-03-2025) Page 107 of 138

 01559847379 http://www.undis.cn/
PKR: 31,000/-
LOA Validity: 23/05/2027

FSC Validity: 30/05/2026

DOC Validity:2028-12-31
211. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
SHIJIAZHUANG Renal Function
M/S ORBIT HIPRO Reagents
DIAGNOSTIC BIOTECHNOLOGY Class B
S Co., LTD
Address of (Manufacturing Shelf Life:
Importer: site) 01 Year
403, PLAZA No. 3 Building,
55, BEHRIA Fangyi Tech. Park, Glycosylated
TOWN-IV, No. 313 Zhujiang Hemoglobin
CIVIC RD, Shijiazhuang, (HbA1c) Test
CENTRE P.R. CHINA Kits: 65322
ISLAMABAD. Alpha-1
PAKISTAN LOA Microglobulin
Valid till 01 April Test Kit: 53923
ELI-00630 2026 Beta-2
Microglobulin
Date of R& I FSC: Test Kit: 53927
13 Sep 2021 Country of Origin Retinol Blinding
China Protein Test Kit:
Fee Details. Validity: 23-11-2025 53971
Fee Challan Cystatin C Test
No. OR Kit: 48178
798161636403 Microalbuminuric
Paid Fee. EC Certificate Test Kit: 59042
25000 CE Certificate Neutrophil
dated 07-09- Validity: April 2027 Gelatinase
2021 Associated
ISO 13485 Lipocalin Test
Validity: 16 July 2026 Kit: 47426
Production Quality
Management Storage Condition:
System Certificate 2-8 C
(ISO 13485:2016)
ISO 13485
Notifying Body
TÜV Rheinland
LGA Products
GmbH
212. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
SHIJIAZHUANG Autoimmunity
M/S ORBIT HIPRO Reagents
DIAGNOSTIC BIOTECHNOLOGY
S Co., LTD Class B
Address of (Manufacturing
Importer: site) Shelf Life:
403, PLAZA No. 3 Building, 01 Year
55, BEHRIA Fangyi Tech. Park,
TOWN-IV, No. 313 Zhujiang Immunoglobulin
CIVIC RD, Shijiazhuang, A Test Kit: 54979

Decisions of 85th Meeting of MDB (21-03-2025) Page 108 of 138

 CENTRE P.R. CHINA Immunoglobulin
ISLAMABAD. E Test Kit: 53782
PAKISTAN LOA Immunoglobulin
Valid till 01 April G Test Kit: 53787
ELI-00630 2026 Immunoglobulin
M Test Kit: 53795
Date of R& I FSC:
13 Sep 2021 Country of Origin Storage Condition:
China 2-8 C
Fee Details. Validity: 23-11-2025
Fee Challan
No. 983821857 OR
Paid Fee.
25000 EC Certificate
dated 07-09- CE Certificate
2021 Validity: April 2027

ISO 13485
Validity: 16 July 2026
Production Quality
Management
System Certificate
(ISO 13485:2016)
ISO 13485
Notifying Body
TÜV Rheinland
LGA Products
GmbH
213. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
SHIJIAZHUANG Infection
M/S ORBIT HIPRO Reagents
DIAGNOSTIC BIOTECHNOLOGY Class B
S Co., LTD
Address of (Manufacturing Shelf Life:
Importer: site) 01 Year
403, PLAZA No. 3 Building,
55, BEHRIA Fangyi Tech. Park, Procalcitonin
TOWN-IV, No. 313 Zhujiang Test Kit: 54316
CIVIC RD, Shijiazhuang, Serum Amyloid A
CENTRE P.R. CHINA Test Kit: 53453
ISLAMABAD. High-Sensitive
PAKISTAN LOA C- Reactive
Valid till 01 April Protein: 53705
ELI-00630 2026
Storage Condition:
Date of R& I FSC: 2-8 C
13 Sep 2021 Country of Origin
China
Fee Details. Validity: 23-11-2025
Fee Challan
No. 312680029 OR
Paid Fee.
25000 EC Certificate
dated 07-09- CE Certificate
2021 Validity: April 2027

ISO 13485
Validity: 16 July 2026

Decisions of 85th Meeting of MDB (21-03-2025) Page 109 of 138

 Production Quality
Management
System Certificate
(ISO 13485:2016)
ISO 13485
Notifying Body
TÜV Rheinland
LGA Products
GmbH
214. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
SHIJIAZHUANG Cardiovascular
M/S ORBIT HIPRO Disease
DIAGNOSTIC BIOTECHNOLOGY Reagents
S Co., LTD
Address of (Manufacturing Class B
Importer: site)
403, PLAZA No. 3 Building, Shelf Life:
55, BEHRIA Fangyi Tech. Park, 01 Year
TOWN-IV, No. 313 Zhujiang
CIVIC RD, Shijiazhuang, D-Dimer Test
CENTRE P.R. CHINA Kit: 47343
ISLAMABAD. Homocysteine
PAKISTAN LOA Test Kit: 53751
Valid till 01 April Heart Fatty Acid
ELI-00630 2026 Binding Protein
Test Kit: 53377
Date of R& I Creatine Kinase
13 Sep 2021 FSC: Isoenzyme MB
Country of Origin Test Kit: 61385
Fee Details. China Cardiac
Fee Challan Validity: 23-11-2025 Troponin I Test
No. 68278541 Kit: 47399
Paid Fee. OR Myohemoglobin
25000 Test Kit: 59042
dated 07-09- EC Certificate Amino-Terminal
2021 CE Certificate pro-brain
Validity: April 2027 natriuretic
peptide Test
ISO 13485 Kits: 47355
Validity: 16 July 2026 Lipoprotein (a)
Production Quality Test Kit: 53438
Management Lipoprotein
System Certificate Phospholipase
(ISO 13485:2016) A2 Test Kit:
ISO 13485 53112
Notifying Body
TÜV Rheinland Storage Condition:
LGA Products 2-8 C
GmbH
215. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
SHIJIAZHUANG 25- Hydroxy-
M/S ORBIT HIPRO Vitamin D Test
DIAGNOSTIC BIOTECHNOLOGY Kit
S Co., LTD (Immune
Address of (Manufacturing Fluorescence
Importer: site) Detection
403, PLAZA No. 3 Building, Method)

Decisions of 85th Meeting of MDB (21-03-2025) Page 110 of 138

 55, BEHRIA Fangyi Tech. Park,
TOWN-IV, No. 313 Zhujiang Class B
CIVIC RD, Shijiazhuang, Shelf Life:
CENTRE P.R. CHINA 01 Year
ISLAMABAD.
PAKISTAN LOA
Valid till 01 April Storage Condition:
ELI-00630 2026 2-8 C

Date of R& I
13 Sep 2021 FSC:
Country of Origin
Fee Details. China
Fee Challan Validity: 23-11-2025
No.
98682668831 OR
Paid Fee.
25000 EC Certificate
dated 07-09- CE Certificate
2021 Validity: April 2027

ISO 13485
Validity: 16 July 2026
Production Quality
Management
System Certificate
(ISO 13485:2016)
ISO 13485
Notifying Body
TÜV Rheinland
LGA Products
GmbH
216. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
HOSPITAL & HOMECARE CARE EAR EYRINGE
M/S IMP. & EXP. CO., LTD,
GHAZALI NANJING Class A
BROTHERS
Address of
Importer Manufacturing Site:
1ST FLOOR ROOM 618-611 NO.5
AZZAINAB ZHONGTAI Shelf Life: 5 Years
COURT INTERNATIONAL PLAZA
CAMPBELL NO.311, JIANGDONG ROAD,
STREET, NANJING, CHINA.
KARACHI, Codes/Sizes:
PAKISTAN Tel: +86-025-87783278
90ml
ELI-00240
LOA:
Original Agency agreement
notarized by CCPIT certificate
Date of R& I no;
03/01/2024 233201A0/001310 dated
2023/02/14
Fee LOA Validity: 10-02-2028
Rs. 5,030/
through slip FSC: - MHRA (UK) FREE SALE
no. CERTIFICATE No.

Decisions of 85th Meeting of MDB (21-03-2025) Page 111 of 138

 984745165022, 2022121902289158/1 dated
dated 12/12/23 19/12/2022
Certified by: Her Majesty’s
Principal Secretary of State
for Foreign and
Commonwealth Affairs, dated
12th Sep 2019,
Validity: 26/05/2025

ISO:
Original Management System
Management System
Certificate
TUV Certificate No:
Q5 064660 0037 Rev.02

Notarized by CCPIT
certificate no;
223201A0/008860

VALID UNTIL: 2025-05-31

217. Applicant Name of Manufacturer: Brand Name: Approved.
Name:
FUJIFILM Corporation Arietta 750 VE
Shirazi 26-30, Nishiazabu 2-chome, (Diagnostic
Trading Minato-ku, Tokyo, 106 Ultrasound
Company 8620, Japan System)
Private
Limited Manufacturing Site: Class B
FUJIFILM Healthcare
114-C, Al Manufacturing Coporation Shelf Life:
Murtaza Kashiwa Office 07 Years
Commercial 2-1, Shintayofuta, Kashiwa (Service Life)
Lane 3, shi, Chiba, 277-0804, Japan
Khayaban-e-
Iqbal, LOA Codes/Sizes:
Phase 8, Validity: 31-08-2025 40761
D.H.A., (GMDN Code)
Karachi. FSC:
Country: Japan
Establishment Validity: N/A
Licence No.:
ELI-00263 CE Certificate
Validity: 28-09-2026
Date of R&I:
24-10-2024 ISO 13485
Validity: 30-11-2026

Fee Challan
No.
6833940550
+
4465916036
Paid fee: 6000
Date: 07-08-
2024

Decisions of 85th Meeting of MDB (21-03-2025) Page 112 of 138

218. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to pay
FUJIFILM Corporation Arietta 65 differential fee of
Shirazi 26-30, Nishiazabu 2-chome, (Diagnostic 6000, As fee revised
Trading Minato-ku, Tokyo, 106 Ultrasound in DRAP Fee
Company 8620, Japan System) Schedule notified in
Private SRO-1324, Dated
Limited Manufacturing Site: Class B 30th August 2024.
FUJIFILM Healthcare
114-C, Al Manufacturing Coporation Shelf Life:
Murtaza Kashiwa Office 07 Years
Commercial 2-1, Shintayofuta, Kashiwa (Service Life)
Lane 3, shi, Chiba, 277-0804, Japan
Khayaban-e-
Iqbal, LOA Codes/Sizes:
Phase 8, Validity: 31-08-2025 40761
D.H.A., (GMDN Code)
Karachi. FSC:
Country: Japan
Establishment Validity: N/A
Licence No.:
ELI-00263 CE Certificate
Validity: 28-09-2026
Date of R&I:
24-10-2024 ISO 13485
Validity: 30-11-2026

Fee Challan
No.
27593623126
Paid fee: 25000
Date: 07-08-
2024
219. Applicant Name of Manufacturer: Brand Name: Approved,
Name: Subject to pay
FUJIFILM Corporation Arietta 750 SE differential fee of
Shirazi 26-30, Nishiazabu 2-chome, (Diagnostic 6000, As fee revised
Trading Minato-ku, Tokyo, 106 Ultrasound in DRAP Fee
Company 8620, Japan System) Schedule notified in
Private SRO-1324, Dated
Limited Manufacturing Site: Class B 30th August 2024
FUJIFILM Healthcare
114-C, Al Manufacturing Coporation Shelf Life:
Murtaza Kashiwa Office 07 Years
Commercial 2-1, Shintayofuta, Kashiwa (Service Life)
Lane 3, shi, Chiba, 277-0804, Japan
Khayaban-e-
Iqbal, LOA Codes/Sizes:
Phase 8, Validity: 31-08-2025 40761
D.H.A., (GMDN Code
Karachi. FSC:
Country: Japan
Establishment Validity: N/A
Licence No.:
ELI-00263 CE Certificate
Validity: 28-09-2026
Date of R&I:
24-10-2024 ISO 13485
Validity: 30-11-2026

Decisions of 85th Meeting of MDB (21-03-2025) Page 113 of 138

 Fee Challan
No.
16757575298
Paid fee: 25000
Date: 07-08-
2024
220. MR Medical M/s Shenzhen Mindray Bio-Medical Brand Name: Approved subject to
Pakistan Pvt Electronics Co., Ltd Mindray submission of fee as
Ltd, Islamabad. Address: Generic Name: per new SRO & valid
Mindray Building, Keji 12th Road Rigid Endoscope Free Sale Certificate
ELI-01008 South, High-Tech Industrial Park, of any reference
Nanshan, 518057, Shenzhen, Class-B country with correct
Application PEOPLE'S REPUBLIC OF CHINA name & address of
Date:23-11- Model number: the manufacturer.
2023 M004
Documents submitted: M029
Fee of Rs. FSC (Germany) issued on G 004
25000/- 06-01-2024 G 029

Receipt No. LOA validity: Shelf life:

307936977340 14-04-2027 10 YEARS

ISO 13485 valid upto 31-08-2026

221. MR Medical M/s Shenzhen Mindray Bio-Medical Brand Name: Approved subject to
Pakistan Pvt Electronics Co., Ltd Mindray submission of fee as
Ltd, Islamabad. Address: Generic Name: per new SRO & valid
Mindray Building, Keji 12th Road Rigid Endoscope Free Sale Certificate
ELI-01008 South, High-Tech Industrial Park, of any reference
Nanshan, 518057, Shenzhen, country with correct
Application PEOPLE'S REPUBLIC OF CHINA Class-B name & address of
Date:12-10- the manufacturer.
2023 Model number:
Documents submitted: M01030A
Fee of Rs. FSC (Germany) issued on M01000A
25000/- 06-01-2024 G01000A
G01030A
Receipt No. LOA validity: Shelf life:
171000126112 14-04-2027 10 YEARS

ISO 13485 valid upto 31-08-2026

222. Electro Med BRAEBON Medical Corporation, Brand Name: Approved subject to
Corporation, 1-100 Schneider Road, Kanata, Ultima Cannula submission of fee as
53 Mall Ontario, K2K Generic Name: per new SRO.
Avenue, 54 The 1Y2, Canada. Nasal Cannula for Sleep Recorders
Mall , Near
Panorama Documents submitted: Class-A
Shopping FSC (Canada) validity
Centre, Lahore. 03-11-2029 Model number:
0582
ELI-00163 LOA validity: 0582-50
24-09-2029 0582PED
Application 0582PED-50
Date: 13-03- ISO 13485 valid upto 18-11-2024 0582S
2025 0582S-50
0582S-F
Fee of Rs. 0582S-F-50
6000/- 0582S-3
0582S-3-50

Decisions of 85th Meeting of MDB (21-03-2025) Page 114 of 138

 Receipt No. 0582S-7
0115262623 0582S-7-50
5582
5582-40
8581
8581-50
8582
8582-50
8582PED
8582PED-50
Shelf life: 5 YEARS
223. Electro Med BRAEBON Medical Corporation, Brand Name: Approved subject to
Corporation, 1-100 Schneider Road, Kanata, MediByte / MediByte Jr submission of fee as
53 Mall Ontario, K2K Generic Name: per new SRO.
Avenue, 54 The 1Y2, Canada. Portable Sleep Data Recorders
Mall , Near Class-B
Panorama Documents submitted:
Shopping FSC (Canada) validity Model number:
Centre, Lahore. 03-11-2029 MBJRK
MP8KN
ELI-00163 LOA validity:
24-09-2029 Shelf life: 4 YEARS
Application
Date: 13-03- ISO 13485 valid upto 18-11-2024
2025

Fee of Rs.
31000/-

Receipt No.
50980659747
224. M/S Universal Legal manufacturer: TDV Dental Crowns Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Dental Crowns) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, Class-A
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 5 years
R & I Details: Codes/sizes:
Dossier Documents submitted: Product Code: As per FSC
Submission
Date: 06-09- LOA:
2023 Validity:22-08-2025
Fee Challan: FSC (electronically signed):
No: 35246262 Brazil issued on 09-03-2022
Dated: 07-12-
2022 ISO 13485 valid upto 25-05-2025
225. M/S Universal Legal manufacturer: TDV Dental Polishing Paste Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Dental polishing Paste) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, Class-A
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 48 months
& I Details: Codes/sizes:
Dossier Documents submitted: Codes/sizes:
Submission Product Code
Date : 06-09- LOA: 0001060000
2023 Validity:22-08-2025 0001060002
Fee Challan: FSC (electronically signed): 0001050000
No: Brazil issued on 09-03-2022
0728880343
Dated: 07-12- ISO 13485 valid upto 25-05-2025

Decisions of 85th Meeting of MDB (21-03-2025) Page 115 of 138

 2022

226. M/S Universal Legal manufacturer: TDV Dental Wedges Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Dental Wedges) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, Class-A
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 5 years
Codes/sizes: As per FSC
R & I Details: Documents submitted:
Dossier
Submission LOA:
Date : 06-09- Validity:22-08-2025
2023 FSC (electronically signed):
Fee Challan: Brazil issued on 09-03-2022
No:
526776690678 ISO 13485 valid upto 25-05-2025
Dated: 07-12-
2022
227. M/S Universal Legal manufacturer: TDV Dental Finishing & Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. polishing strips submission of fee as
17- Mcleod ADDRESS: XV DE Novembro (Dental Finishing & polishing per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, strips)
ELI-00071 State Of Santa Catarina, Brazil.
Class-A
R & I Details: Documents submitted: Shelf life: 5 years
Dossier Codes/sizes: As per FSC
Submission LOA:
Date : 06-09- Validity:22-08-2025
2023 FSC (electronically signed):
Fee Challan: Brazil issued on 09-03-2022
No:
4136615975 ISO 13485 valid upto 25-05-2025
Dated: 07-12-
2022.
228. M/S Universal Legal manufacturer: TDV Dental Matrices System Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Dental Matrices system) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, Class-A
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 5 years
Codes/sizes: As per FSC
R & I Details: Documents submitted:
Dossier
Submission LOA:
Date : 06-09- Validity:22-08-2025
2023 FSC (electronically signed):
Fee Challan: Brazil issued on 09-03-2022
No:
72850555423 ISO 13485 valid upto 25-05-2025
Dated: 07-12-
2022.
229. M/S Universal Legal manufacturer: TDV Tools for Dentistry Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Tools for Dentistry) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO.
Road, Lahore. Street, # 9944, City of Pomerode, Class-A
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 5 years
Codes/sizes:
R & I Details: Documents submitted: 0005020002
Dossier 0005040000
Submission LOA: 0005040016

Decisions of 85th Meeting of MDB (21-03-2025) Page 116 of 138

 Date : 06-09- Validity:22-08-2025 0005040023
2023 FSC (electronically signed): 0005040024
Fee Challan: Brazil issued on 09-03-2022 0005040025
No: 0005040026
53403531055 ISO 13485 valid upto 25-05-2025 0005040027
Dated: 07-12- 0005030003
2022 0005030006
0005030009
0005010000
230. M/S Universal Legal manufacturer: TDV Finishing & polishing Discs Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Finishing & polishing sandpaper submission of fee as
17- Mcleod ADDRESS: XV DE Novembro Discs) per new SRO & valid
Road, Lahore. Street, # 9944, City of Pomerode, FSC of reference
ELI-00071 State Of Santa Catarina, Brazil. Class-B country or EC
Shelf life: 5 years Certificate.
R & I Details: Documents submitted: Codes/sizes:
Dossier 0005020002
Submission LOA: 0005040000
Date : 06-09- Validity:22-08-2025 0005040016
2023 FSC (electronically signed): 0005040023
Fee Challan: Brazil issued on 09-03-2022 0005040024
No: 0005040025
314195573726 ISO 13485 valid upto 25-05-2025. 0005040026
Dated: 07-12- 0005040027
2022 EC Certificate: 0005030003
Validity: 31-12-2028 0005030006
0005030009
0005010000
231. M/S Universal Legal manufacturer: Optimize Approved subject to
Dental Pvt. Ltd, TDV Dental LTDA. (Finishing & Polishing material) submission of fee as
17- Mcleod ADDRESS: XV DE Novembro per new SRO & valid
Road, Lahore. Street, # 9944, City of Pomerode, Class-B FSC of reference
ELI-00071 State Of Santa Catarina, Brazil. Shelf life: 5 years country or EC
Codes/sizes: Certificate.
R & I Details: Documents submitted: 0000000003
Dossier 0000000009
Submission LOA: 0000000010
Date : 06-09- Validity:22-08-2025 0000000011
2023 FSC (electronically signed): 0000000012
Fee Challan: Brazil issued on 09-03-2022 0010010016
No: 516936057 0010010004
Dated: 07-12- ISO 13485 valid upto 25-05-2025.
2022
232. M/S GHAZALI Meidile (Ningbo) Mother ACCUMAX BREAST PUMP Approved subject to
BROTHERS And Infant Products CO. submission of
1ST FLOOR LTD., Class A evidence of
AZZAINAB NO.3-1 South Gongji submission of fee
COURT Road, Linshan Town, Shelf Life: 5 Years along with R&I
CAMPBELL Yuyao City, Zhejiang receiving.
STREET, Province, PRC. Codes/Sizes:
KARACHI, AX-900, AX-800, AX-188
PAKISTAN Documents submitted: (W188), AX-999 (DQ-S001-
999), AX-111-1001 (D-111-
ELI-00240 LOA: 1001), AX-188-999 (RH-
Date of R& I Validity: 22nd Oct, 2027 188-999), AX-01-99 (S01-
13th March FSC: China S99), AX-189-999 (W189-
2023 Validity: Oct, 2022. 999)
Fee
Rs. 5,000/

Decisions of 85th Meeting of MDB (21-03-2025) Page 117 of 138

 through slip no.
136672990,
dated
07/03/2023
233. Cardiac Care VYGON CVP manometer Approved
848-C Shadman Address: 5 rue Adeline - 95440 (Manometer tube for venous
-1, Lahore Ecouen – FRANCE. pressure measurement + extension
ELI-00070 Documents submitted: line)
R&I 03-03-
2020 FSC issued date: 24/07/2023 Class A
Fee Challan No LOA valid : 31/12/2026 Shelf Life:
Cardiac Care 05 years
848-C Shadman ISO 13485 valid upto 09-05-2027
-1, Lahore Codes
ELI-00070 80297.00C
R&I 03-03-
2020
Fee Challan No
1931030 dated
28-02-20 dated
28-02-20
234. Radiant Inami & Co. Ltd., L‐0187‐LED Approved
Medical Private 24‐2, Hongo 3‐Chome, Bunkyo‐ku, LED Slit Lamp
Limited Tokyo 113‐0033, Japan.
06‐Sher Shah Class A
Block New Documents submitted: Shelf Life:
Garden Town 07 years
Lahore, FSC issued date: 15/10/2024
Pakistan. Codes
ELI-00135 LOA valid : 01/10/2025 80297.00C

Date of R& I ISO 13485 valid upto 31-07-2027

28-Jan-2025
Fee
Rs. 5,000/,
Fee Challan No
1931030
235. New Pakistan BonreeMedical Co., Ltd. COMFORT CARE AEROSOL Approved subject
Traders. Office Address: No.4 Longzhu Garden, MASK clarification of the
No. 306/I, Wanmu Industrial Estate, brand name as per
Trade Tower, Nanlang 528451, Zhongshan, CLASS: B FSC and submission
Altaf Hussain Guangdong, People’s Republic of valid Ce
Road, New Of China Shelf life certificate
Challi, 5 years
Karachi- LOA:
74000, Validity: 31/12/2030 SIZES: ADULT/CHILD/
Pakistan PEDIATRIC/NEW BORN
Lic. No. FSC: CHINA
ELI-00161 ISSUANCE DATE: 25/10/2023 Submission
VALIDITY: 24/10/2025 16/07/2020
R&I:
16/07/2020 ISO 13485:
ISSUANCE DATE: 06/09/2022
EXPIRY DATE: 31/07/2025

EC Certificate:
ISSUANCE DATE: 10/02/2020
EXPIRY DATE: 26/05/2024

Decisions of 85th Meeting of MDB (21-03-2025) Page 118 of 138

236. New Pakistan BonreeMedical Co., Ltd. K&K TRACHAEL TUBE Approvedcuffed
Traders. Office Address: No.4 Longzhu Garden, subject to
No. 306/I, Wanmu Industrial Estate, CLASS: B submission of the
Trade Tower, Nanlang 528451, Zhongshan, valid CE certificate
Altaf Hussain Guangdong, People’s Republic Shelf life and brand name
Road, New Of China 5 years clarification since in
Challi, the FSC is
Karachi- LOA: SIZES: Endotracheal tube
74000, Validity: 31/12/2030 CUFFED and applied is K&K
Pakistan :2.5/3.0/3.5/4.0/4.5/5.0/5.5/ TRACHAEL TUBE
Lic. No. FSC: CHINA 6.0/6.5/7.0/7.5/8.0/8.5/9.0
ELI-00161 ISSUANCE DATE: 25/10/2023
VALIDITY: 24/10/2025 UNCUFFED
R&I: :2.5/3.0/3.5/4.0/4.5/5.0/5.5
16/07/2020 ISO 13485:
ISSUANCE DATE: 06/09/2022 Submission
EXPIRY DATE: 31/07/2025 16/07/2020

EC Certificate:
ISSUANCE DATE: 10/02/2020
EXPIRY DATE: 26/05/2024
Renewal applied
237. New Pakistan BonreeMedical Co., Ltd. COMFORT CARE OXYGEN Approved subject to
Traders. Office Address: No.4 Longzhu Garden, MASK submission of the
No. 306/I, Wanmu Industrial Estate, CE certificate and
Trade Tower, Nanlang 528451, Zhongshan, CLASS: B R&I receiving’s and
Altaf Hussain Guangdong, People’s Republic valid fee slip
Road, New Of China Shelf life
Challi, 5 years
Karachi- LOA:
74000, Validity: 31/12/2030 SIZES: ADULT/CHILD/
Pakistan PEDIATRIC
Lic. No. FSC: CHINA
ELI-00161 ISSUANCE DATE: 25/10/2023 Submission
VALIDITY: 24/10/2025 16/07/2020
R&I:
16/07/2020 ISO 13485:
ISSUANCE DATE: 06/09/2022
EXPIRY DATE: 31/07/2025

EC Certificate:
ISSUANCE DATE: 10/02/2020

238. New Pakistan Jiangsu Weikang Jiejing Medical GREEN Deferred for
Traders. Office Apparatus Co.,Ltd DISPOSABLE sterile submission of the
No. 306/I, Address: No.18,Wenzhou CATHETERS brand name
Trade Tower, Road,Economic Development clarification or
Altaf Hussain District, Shuyang, Jiangsu SIZE & MODEL: revise the From 7A
Road, New Province, China. Disposable Foley Catheter as per FSC. Also
Challi, (Fr6,fr8,fr10,fr12,fr14,fr16, provide valid Ce
Karachi- LOA: fr18,fr20,fr22,fr24,fr26,fr28) certificate
74000, Validity: not written Disposable Suction Catheter Provide fresh LOA
Pakistan (Fr6,fr8,fr10,fr12,fr14,fr16,
Lic. No. FSC: CHINA fr18,fr20)
ELI-00161 27/11/2025 Disposable Nelaton Catheter
(Fr6,fr8,fr10,fr12,fr14,fr16,
R&I: ISO 13485: fr18,fr20,fr22,fr24,fr26,fr28,
28/02/2020 ISSUANCE DATE: 21/04/2023 fr30,fr32,fr34)
EXPIRY DATE: 28/04/2025

Decisions of 85th Meeting of MDB (21-03-2025) Page 119 of 138

 EC Certificate:
ISSUANCE DATE: 26/04/2019 CLASS: B
EXPIRY DATE: 16/04/2025
Shelf life
5 years

Submission
28/02/2020
239. New Pakistan Jiangsu Weikang Jiejing Medical GREEN Deferred for
Traders. Office Apparatus Co.,Ltd DISPOSABLE STERILE TUBES submission of
No. 306/I, Address: No.18,Wenzhou clarification
Trade Tower, Road,Economic Development SIZE & MODEL: regarding the brand
Altaf Hussain District, Shuyang, Jiangsu Disposable Stomach Tubes name as per FSC
Road, New Province, China. (Fr6,fr8,fr10,fr12,fr14,fr16, and revise form 7A.
Challi, fr18,fr20) also provide valid
Karachi- LOA: Disposable Feeding (Nasogastric) Ce certificate and
74000, Validity not writen issued in 2019 Tubes fresh LOA
Pakistan (fr4,fr5,fr6,fr7,fr8,fr10,fr12,
Lic. No. FSC: CHINA fr14)
ELI-00161 27/11/2025

R&I: ISO 13485: CLASS: B

28/02/2020 ISSUANCE DATE: 21/04/2023
EXPIRY DATE: 28/04/2025 Shelf life
5 years
EC Certificate:
ISSUANCE DATE: 26/04/2019
EXPIRY DATE: 16/04/2024 Submission
28/02/2020
240. New Pakistan Jiangsu Weikang Jiejing Medical COMFORT CARE Approved subject to
Traders. Office Apparatus Co.,Ltd NASAL OXYGEN CANNULA submission of the
No. 306/I, Address: No.18,Wenzhou valid Ce certificate
Trade Tower, Road,Economic Development SIZE: and fresh LOA
Altaf Hussain District, Shuyang, Jiangsu ADULT/CHILD/
Road, New Province, China. PEDIATRIC/NEW BORN
Challi,
Karachi- LOA: CLASS: B
74000, Validity: 31/12/2030
Pakistan Shelf life
Lic. No. FSC: CHINA 5 years
ELI-00161 27/11/2025

R&I: ISO 13485: Submission

28/02/2020 ISSUANCE DATE: 21/04/2023 28/02/2020
EXPIRY DATE: 28/04/2025

EC Certificate:
ISSUANCE DATE: 26/04/2019
EXPIRY DATE: 16/04/2025

241. New Pakistan M/S. SHANGHAI KINMED COMFORT CARE SUCTION Deferred for
Traders. Office IMPORT & EXPORT CO., LTD CONNECTING TUBE WITH submission of the
No. 306/I, ADD: SUIT L, 12TH FLOOR, YANKUER HANDLE embassy attested
Trade Tower, NO.588 YINGKOU ROAD, valid FSc and
Altaf Hussain SHANGHAI, CHINA CLASS: B notarized CE
Road, New Tel:+86 21 61172171 certificate
Challi, Fax:+86 21 61172173 Shelf life

Decisions of 85th Meeting of MDB (21-03-2025) Page 120 of 138

 Karachi- 5 years
74000, LOA:
Pakistan Validity: 31/12/2030
Lic. No.
ELI-00161 FSC: CHINA
20/12/2025
R&I:
08/01/2025 ISO 13485:
ISSUANCE DATE: 14/09/2024
EXPIRY DATE: 26/09/2027

EC Certificate:
ISSUANCE DATE: 21/05/2024
EXPIRY DATE: 20/05/2029

242. New Pakistan M/S. SHANGHAI KINMED COMFORT CARE DISPOSABLE Approved subject to
Traders. Office IMPORT & EXPORT CO., LTD SURGICAL BLADE (without submission of the
No. 306/I, ADD: SUIT L, 12TH FLOOR, handle ) R&I receiving’s and
Trade Tower, NO.588 YINGKOU ROAD, Ce certificate
Altaf Hussain SHANGHAI, CHINA SIZE:
Road, New Tel:+86 21 61172171 10g/11g/12g/15g/20g/21g/22g/23g/
Challi, Fax:+86 21 61172173 24g
Karachi-
74000, LOA: CLASS: B
Pakistan Validity: 31/12/2030
Lic. No. Shelf life
ELI-00161 FSC: CHINA 5 years
20/12/2025
R&I:
08/01/2025 ISO 13485:
ISSUANCE DATE: 14/09/2024
EXPIRY DATE: 26/09/2027

EC Certificate:
ISSUANCE DATE: 21/05/2024
EXPIRY DATE: 20/05/2029

243. New Pakistan ZIBO EASTMED COMFORT CARE I.V. FLOW Approved subject to
Traders. Office HEALTHCARE PRODUCTS REGULATOR (DIA FLOW) submission of the
No. 306/I, CO., LTD notarized and valid
Trade Tower, NO.118, HUAGUANG ROAD, CLASS: B CE certificate along
Altaf Hussain ZHANGDIAN DISTRICT, ZIBO with the valid FSC
Road, New 255000, SHANDONG, CHINA Shelf life having the applied
Challi, 5 years product.
Karachi- LOA: Submit stability
74000, Validity: 25/12/2029 studies
Pakistan
Lic. No. FSC: CHINA
ELI-00161 27/12/2027

R&I: ISO 13485:

08/01/2025 ISSUANCE DATE: 17/08/2022
EXPIRY DATE: 16/08/2025

244. Name Rech Arthrex, Inc. 1370 Creekside ACP Double syringe Deferred for
International, Boulevard Naples 34108-1945 USA submission of the
Karachi FSC embassy attested FSC
Address of Submit Revised Form

Decisions of 85th Meeting of MDB (21-03-2025) Page 121 of 138

 Importer 247/B, Valid til 19.09.2026 Class A 7A having the correct
Block 6 PECHS LOA- Validity- 30TH June,2027 Shelf life N/A class and submit
Shahrah-e- ISO 13485- Validity 21-11-2025 ABS-1001 ABS-1001-L ABS-1001- differential fee
Faisal Karachi Full Quality Assurance Certificate S ABS-10010S ABS-10011 ABS-
Or Equivalent: FQA-Validity- 26- 10014 ABS-1002 ABS-10026-15
Fee 5000 05-24 ABS-10027 ABS-10064 ABS-
10066 ABS-1050 ABS-10080
HORIZON 24-AH ABS-10056
37227 AR-10055
245. Name Rech Arthrex, Inc. 1370 Creekside Scopes Deferred for
International, Boulevard Naples 34108-1945 USA submission of the
Karachi FSC Class A embassy attested FSC
Address of or clarify the brand
Importer 247/B, Valid til 19.09.2026 Shelf life N/A name. Submit
Block 6 PECHS LOA- Validity- 30TH June,2027 Revised Form 7A
Shahrah-e- ISO 13485- Validity 21-11-2025 AR-3000AW AR-3350- 1930 having the correct
Faisal Karachi Full Quality Assurance Certificate AR3350-2430 AR-3350-2470 class and submit
Or Equivalent: FQA-Validity- 26- AR3350-2730 AR-3350- 2770 AR- diffrential fee
Date of R& I 05-24 3350-2930 AR-3350-3030 AR3350-
Submission 3070 AR-3350- 4030H AR-3350-
date: Aug,2024 4030R AR-3350-4031 AR-3350-
Fee Rs 5,000 4070H AR3350-5230 AR-3350-
5270 AR-3351-1000 AR-3351-
1000L AR3351-1030 AR-3351-
1030L AR-3351-1045 AR-3351-
1045L AR3351-3030 AR-3351-
5500 AR-3351-5500L AR-3351-
5530 AR3351-5530L AR3351-5545
AR-3351- 5545L AR-3352-5500
AR-3352-5500L AR3352-5530 AR-
3352- 5530L AR-3352-5545 AR-
3352-5545L AR3355-0001 AR-
3355- 1930 AR-3355-2430 AR-
3355-2470 AR3355-2730 AR-3355-
2770 AR-3355-3070 AR-3355-4000
AR3355-4030 AR-3355- 4030H
AR-3355- 4030R AR-3355-4031
AR-3355-4070H AR3355-5230
AR-3355- 5270 S76248 AR-3350-
4030H AR3350-4071 AR-3351-
1031 AR-3352-5531 AR-3351-1001
AR3352-5501
246. Name Rech Arthrex, Inc. 1370 Creekside Arthroscopic hand set (Instruments) Deferred for
International, Boulevard Naples 34108-1945 USA Class A submission of the
Karachi FSC embassy attested
Address of Shelf life N/A FSC R&I receiving
Importer 247/B, Valid til 19.09.2026 Fee slip
Block 6 PECHS LOA- Validity- 30TH June,2027
Shahrah-e- ISO 13485- Validity 21-11-2025
Faisal Karachi Full Quality Assurance Certificate
Or Equivalent: FQA-Validity- 26-
Date of R& I 05-24
Submission
date: Aug,2024
Fee Rs 5,000
247. Name Rech Arthrex, Inc. 1370 Creekside Power and shaver Deferred for
International, Boulevard Naples 34108-1945 USA submission of the
Karachi FSC Class A embassy attested
Address of AR-8300 AR-8305 AR-8310 AR- FSC or clarify the

Decisions of 85th Meeting of MDB (21-03-2025) Page 122 of 138

 Importer 247/B, Valid til 19.09.2026 8315C brand name. Submit
Block 6 PECHS LOA- Validity- 30TH June,2027 AR-8330F AR-8330FK AR- Revised Form 7A
Shahrah-e- ISO 13485- Validity 21-11-2025 8330FO AR-8330H AR-8330RH having the correct
Faisal Karachi Full Quality Assurance Certificate AR-8330SJ AR-8330SJO AR- class and submit
Or Equivalent: FQA-Validity- 26- 8330SJV AR-8330TK AR-8330TO diffrential fee
Date of R& I 05-24 AR-8330V AR-8330VO AR-8332H
Submission AR-8332RH AR-8350CDS AR-
date: Aug,2024 8350DS AR-8350PR AR-8350ST
Fee Rs 5,000 AR-8380BC AR-8380DC AR-
8380DS AR-8380EX AR-8380SR
AR-8380ST AR-8380SW AR-
8400BC AR-8400CBC AR-
8400CDC AR-8400CDS AR-
8400CEX AR-8400CRE AR-
8400CSR AR-8400CSS AR-
8400CST AR-8400CTD AR-
8400CTS AR-8400DC AR-8400DS
AR-8400EX AR-8400HSO AR-
8400OBE AR-8400PR AR-
8400RBE AR-8400SR AR-8400ST
AR-8400TD AR-8402C AR-8485-
14 AR-8500BC AR-8500BL AR-
8500COE AR-8500COT AR-
8500CRE AR-8500DS AR-8500EX
AR-8500FOE
AR-8500FOS AR-8500FOT AR-
8500HSO AR-8500OBE AR-
8500RBE AR-8500SR AR-8500ST
AR-8500TBT AR-8500TD AR-
8550BC AR-8550COE AR-
8550COS AR-8550COT AR-
8550CRE AR-8550DC AR-8550DS
AR-8550EX AR-8550FOE AR-
8550FOS AR-8550FOT AR-
8550HSO AR-8550OBT AR-
8550PR AR-8550RBE AR-8550SR
AR-8550ST AR-7300DS AR-
7300OBT AR-7300RBE AR-
7300SR AR-7400TD "AR-
8500OBE (8-flute)" AR-200 AR-
400DAO AR-400 AR-400UBH
AR-400ATK AR-400UBC AR-
400UBC-4 AR-400WMC AR-
400SAG AR-400DK74 AR-
400DJ40 AR-400DJ74 AR-
400DJH50 AR-400DJH74 AR-
400DZH AR-400DT AR-400DHA
AR-400ARL AR-400RZH AR-
400UB AR-400PD AR-200C AR-
200M AR-200M-ISO AR-200SP
AR-300 AR-300-040S AR-300-
041S AR-300-042S AR-300-043S
AR-300-044S AR-300-045S AR-
300-050S AR-300-051S AR-300-
052S AR-300-406S AR-300-407S
AR-300-450S AR-300-B001 AR-
300-B002 AR-300-B003 AR-300-
B004 AR-300-B101 AR-300-B102
AR-300-B201 AR-300-B202 AR-

Decisions of 85th Meeting of MDB (21-03-2025) Page 123 of 138

 300-B301S AR-300/600F-EU AR-
300ATK AR-300B AR-300B-2 AR-
300C AR-300C-G AR-300CA AR-
300DAO-2 AR-300DJ AR-300DJH
AR-300DK30 AR-300DK45 AR-
300E AR-300H AR-300HKEY AR-
300KEY AR-300L AR-300LBH
AR-300PD24 AR-300RAO AR-
300RJ AR-300SAG AR-300SR
AR-300WD16 AR-600 AR-600-
000S AR-600-001S AR-600-002S
AR-600-003S AR-600-004S AR-
600-005S AR-600-006S AR-600-
007S AR-600-010S AR-600-011S
AR-600-012S AR-600-013S AR-
600-020S AR-600-021S AR-600-
022S AR-600-025S AR-600-026S
AR-600-050S AR-600-051S AR-
600-052S AR-600-053S AR-600-
103S AR-600-104S AR-600-106S
AR-600-107S AR-600-110S AR-
600-150S AR-600-151S AR-600-
250S AR-600-300S AR-600-301S
AR-600-302S AR-600-303S AR-
600-304S AR-600-305S AR-600-
306S AR-600-307S AR-600-310S
AR-600-311S AR-600-312S AR-
600-313S AR-600-350S AR-600-
351S AR-600-352S AR-600-353S
AR-600ARL AR-600ATK AR-
600C AR-600C-G AR-600DAO
AR-600DAOP AR-600DAOT AR-
600DJ AR-600DJH AR-600DK
AR-600DZH AR-600GC AR-
600HKEY AR-600KEY AR-600L
AR-600LBH AR-600PD-2 AR-
600PD-3 AR-600RAOP AR-600RJ
AR-600RK AR-600RZH AR-
600SAG AR-600SAGAO AR-
600SAGMIS AR-600SAGS AR-
600SR AR-600SRS AR-600WD-2
OEM01525000 OEM04005900
OEM04013500 OEM04364100
OEM04653500 OEM04725700
OEM04725900 OEM04726000
OEM04726100 OEM04726200
OEM04800400 OEM04800500
OEM06202400 OEM06290600 AR-
400UBH-1 AR-400ATK-1 AR-
400RJ74 AR-400RAOP AR-
400DHS AR-400UBC-3 AR-
600DHS AR-600C-3 AR-400AC-1
S-N1 AR-200H AR-200CA AR-
400DS AR-400PRAO AR-
400PRMT AR-400PRHU AR-
400SR 220500799 220501330
220202293 220501328 AR-600-
301S AR-600-302S AR-600-353S

Decisions of 85th Meeting of MDB (21-03-2025) Page 124 of 138

248. M/s RECH /s Beijing Libeier Bio-engineering Brand Name; Soprano Posterior Deferred for
International, Institute Co., Ltd. 12 Chuangxin cervical screw rod system submission of the
Karachi ELI- Road, Changping Science and instrument set valid and embassy
00257 Technology Park, Changping Area, attested FSC valid
Beijing, P. R. China FSC: China Generic Name; Orthopedic Manual Ce certificate.
Validity: 2025.10.26 LOA Validity: Surgical Instrument Set Submit R&I
31-Dec-2026 Class A receiving and fee
slip.
249. NI healthcare Legal Manufacturer: Nanyang Major Brand Name: WARMA Approved
products Pvt Medical Products Co Ltd Address: Hyperthermia System full body
Ltd Office No. No. 16 County Road, Jinhua Town, Blanket
A, Unit 10 Wenchang District, Nanyang City, Generic Name: Warming Blanket
Survey No. 263, Henan Province, China FSC: China Class: A
Damlotte Road Validity: 29-02-2024 LOA 04-01- Shelf Life: 5 years Sizes: 220*120
District Malir, 2029 cm 230*75cm 120*100cm
Karachi ELI- 140*100cm
01117
250. NI healthcare Legal Manufacturer: Medcaptain Brand Name: Navi-60 Generic Approved
products Pvt Medical Technology CO Ltd. Legal Name: Vienilluminator (Finder)
Ltd Office No. Address: 12th floor Baiwang Class: A
A, Unit 10 No.5158 Shahe West Road, Xili, Shelf Life: 05years
Survey No. 263, Nanshan, 518055 Shenzhen,
Damlotte Road Guangdong, Peoples Republic of
District Malir, China Manufacturing Address
Karachi ELI- Medcaptain Medical Technology CO
01117 Ltd. Building C Jiale Science and
Technology Industrial Park Matian
Street, Guangming 518106 Shenzen,
Guangdong, Peoples Republic of
China Tel: +86-755-269563369 Fax:
+86-755-26001651
[email protected] om FSC:
China Validity: 19-12-2024 LOA
Validity: 14-08-2027
251. NI healthcare Manufacturer: Medcaptain Medical Brand Name: Video Laryngoscope Approved
products Pvt Technology CO Ltd. Legal Address: VS10S/VS-10M/VS10H Generic
Ltd Office No. 12th floor Baiwang No.5158 Shahe Name: Video Laryngoscope Class:
A, Unit 10 West Road, Xili, Nanshan, 518055 A Shelf Life: 05years
Survey No. 263, Shenzhen, Guangdong, Peoples
Damlotte Road Republic of China Manufacturing
District Malir, Address Medcaptain Medical
Karachi ELI- Technology CO Ltd. Building C
01117 Jiale Science and Technology
Industrial Park Matian Street,
Guangming 518106 Shenzen,
Guangdong, Peoples Republic of
China

FSC: China Validity: 19-03-2025

LOA Validity: 14-08-2027
252. NI healthcare Legal Manufacturer: Mcreat Brand Name: Mcreat Suction Liner Approved with the
products Pvt (GUAGNZHOO) Bio-Tech CO. Ltd Bag and Canister Generic Name: Suction Liner Bag
Ltd Office No. Address: 3rd Floor, b15 Huachuang Suction Liner Bag and Canister
A, Unit 10 Industry Area Jinshan, Shiji Town, Class A
Survey No. 263, Panyu District, Guangzhou, Shelf Life: 02years Sizes: 1500ml
Damlotte Road Guangdong China. FSC: China 2000ml 2500ml
District Validity: 24-03-2026 LOA Validity:
Malir,Karachi 31-12-2026
ELI-01117

Decisions of 85th Meeting of MDB (21-03-2025) Page 125 of 138

253. Alpha Initiative Legal Manufacturer: Brand Name: Tecsoft tetra Approved
(Private) The Fred Hollows Intraocular Lens (Generic name): Sterile
Limited Laboratory Tilganga Eye Center Foldable Acrylic Intraocular
Address: Suite P.O.Box # 561,Postal Code#44600, Lens.
# 9, Ground Gaushala, Kathmandu, Nepal
Floor, (+977) 1 597 0048 Class: C
Khudadad
Heights, Main FSC: Shelf Life: 4 years
Margala Road, Country
E-11, Islamabad Validity: 29-04-2025 Group: Single
(ELI-01278)
LOA
Validity: 24-09-2028

CE Certificate
Validity: 31-12-2027
ISO 13485
Validity: 08-12-2025

254. Alpha Initiative Legal Manufacturer: Brand Name: Tecsoft Flex Approved
(Private) The Fred Hollows Intraocular Lens (Generic name): Sterile
Limited Laboratory Tilganga Eye Center Foldable Acrylic Intraocular
Address: Suite P.O.Box # 561,Postal Code#44600, Lens.
# 9, Ground Gaushala, Kathmandu, Nepal
Floor, (+977) 1 597 0048 Class: C
Khudadad
Heights, Main FSC: Shelf Life: 4 years
Margala Road, Country
E-11, Islamabad Validity: 29-04-2025 Group: Single
(ELI-01278)
LOA
Validity: 24-09-2028

CE Certificate
Validity: 31-12-2027
ISO 13485
Validity: 08-12-2025

255. Alpha Initiative Legal Manufacturer: Brand Name: The Fred Approved
(Private) The Fred Hollows Intraocular Lens Hollows, One Sterile
Limited Laboratory Tilganga Eye Center Intraocular lens
Address: Suite P.O.Box # 561,Postal Code#44600, (Generic name): Sterile One
# 9, Ground Gaushala, Kathmandu, Nepal Piece Rigid PMMA
Floor, (+977) 1 597 0048 Intraocular Lens.
Khudadad
Heights, Main FSC: Class: C
Margala Road, Country
E-11, Islamabad Validity: 29-04-2025 Shelf Life: 5 years
(ELI-01278)
Group: Single
LOA
Validity: 24-09-2028 Codes/Sizes: Model FA60B
CE Certificate
Validity: 31-12-2027
ISO 13485
Validity: 08-12-2025

Decisions of 85th Meeting of MDB (21-03-2025) Page 126 of 138

256. Approved YBH
ELATE CC Legal Brand Name Disposable
PVT LTD Manufacturer: YBH Disposable Anesthesia
Suite No.1, 2, Shaoxing Undis Anesthesia Breathing Circuit
3, ST-3, Block- Medical Breathing subject to
3, Gulshan-e- Technology Co., Circuit with submission of the
Iqbal, Karachi- Ltd Accessories R&I receiving and
Pakistan. Manufacturing Generic Name fee slip along with
ELI-00294 Site: ANESTHESIA the stability studies.
No. 12 Yuexing BREATHING Apply and submit
Technology Park, CIRCUIT separate fee for the
No. 11 Fanrong Class B others
Road, Binhai New Shelf Life: 3 years
Area, 312366 for Anesthesia
Shaoxing, Zhejiang Breathing
Province, Circuit , Silicone
PEOPLE'S breathing
REPUBLIC OF circuit,
CHINA, Disposable
Date of R&I Breathing Filter,
31-12-2024 Breathing Bags
FSC: 5 years for
Country of Origin- Disposable
China Heated Wire
Validity: 13-DEC- circuit
2026 Codes/Sizes:
FSC: ANESTHESIA
Applied on CE BREATHING
LOA CIRCUIT
Validity: 30-12- ACCA-160、
2027 ACCA-240、
ACCP-160、
EC Certificate
ACCN-160、
Validity: 19-06-2023
Extension letter attached BCCA-160、
ISO 13485 BCCA-240,
Validity: 19-06-2025 BCCP-160、
BCCN-160
Silicone
breathing circuit
HXG-09-04,
HXG-09-05,
HXG-09-06
Disposable
Heated Wire
circuit
、CH0102
Disposable
Breathing Filter
HMEF02、
HMEF03、
HMEF04
Breathing Bags
HXN-02-01、

Decisions of 85th Meeting of MDB (21-03-2025) Page 127 of 138

 HXN-02-02、
HXN-02-03

257. ELATE CC Legal Manufacturer: Brand Name Nasal Interface Approved Nasal
PVT LTD M/s Armstrong Medical Ltd Generic Name Interface subject to
Suite No.1, 2, 3, Manufacturing Site: Nasal Cannula submission of the
ST-3, Block-3, Wattstown Business Park, Class B R&I receiving and
Gulshan-e- Newbridge Road, Coleraine Shelf Life: 5 years fee slip along with
Iqbal, Karachi- BTS52 IBS , Codes/Sizes: the stability studies.
Pakistan. Date of R&I Aquanase Apply and submit
ELI-00294 31-12-2024 AMNS-1005, AMNS- 1004-002, separate fee for the
FSC: AMNS-2006- 002, AMNS-2004- others
Country of Origin- UK 002, AMNS-1006, AMNS- 1006-
Validity: 12-05-2029 002, AMNS-2005- 002, AMNS-
LOA 2005, AMNS-2004.
Validity: 30-12-2027 Neonatal and Paediatric High
EC Certificate Flow Cannula
Validity: 19-04-2023 AMNC-2005, AMNC- 2004,
Extension letter attached AMNC-2003, AMNC-2002,
ISO 13485 AMNC-2001
Validity: 19-04-2026
258. ELATE CC Legal Manufacturer: Brand Name AQUAVENT CPAP Approved
PVT LTD M/s Armstrong Medical Ltd SYSTEM AQUAVENT CPAP
Suite No.1, 2, 3, Manufacturing Site: Generic Name SYSTEM subject to
ST-3, Block-3, Wattstown Business Park, CPAP SYSTEM submission of the
Gulshan-e- Newbridge Road, Coleraine, Class B R&I receiving and
Iqbal, Karachi- Date of R&I Shelf Life: 5 years fee slip along with
Pakistan. 31-12-2024 Codes/Sizes: the stability studies.
ELI-00294 FSC: Aquavent CPAP system Apply and submit
Country of Origin- UK AMPCPUK01272, separate fee for the
Validity: 12-05-2029 AMPCPUK01275, others
LOA AMPCPUK01258, AMCP1408-
Validity: 30-12-2027 003, AMCP1408-002, AMCP1408-
EC Certificate 011
Validity: 19-04-2023 Aquavent Heated humidified
Extension letter attached oxygen system
ISO 13485 AMHO1509-008, AMHO1509-055,
Validity: 19-04-2026 AMHO1509-050, AMHO1509-017,
PEP Valves

Decisions of 85th Meeting of MDB (21-03-2025) Page 128 of 138

 AMPV8015, AMPV8012,
AMPV8010, AMPV8007,
AMPV8005, AMPV8003.
Accessories
Aquavent Gas Flow Driver
AMFD140i-UK, AMFD140i-UK2
259. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Ve Uretim VE Pressure Monitoring Set submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SB00020DN 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara SB00020SN Ce certificate. Also
C, 12th Turkiye submit Fee slip and
Commercial Class B stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01- Fee Rs. 25000/-
Extension, 2022 Valid for 36 Months) Shelf Life 03 Years
Defence
Housing Turkey and EU
Authority,
Karachi-75500, Letter of Authorization:
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:
Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025
Production Quality Assurance
Submission Certificate: Attached with Dossier
Detail: CE:

Amount: CE Turkey Issued on 29-04-2021

25,000/-
Challan No. Valid Till 27-05-2024
97369378126

260. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Ve Uretim VE Extension Line submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara SL50120EN Ce certificate. Also
C, 12th Turkiye SL10100CN submit Fee slip and
Commercial stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01- SL10085CN
Extension, 2022 Valid for 36 Months) SL10460CN
Defence
Housing Turkey and EU Class B
Authority, Fee Rs. 25000/-
Karachi-75500, Letter of Authorization: Shelf Life 03 Years
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:
Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025
Production Quality Assurance

Decisions of 85th Meeting of MDB (21-03-2025) Page 129 of 138

 Submission Certificate: Attached with Dossier

Detail: CE:

Amount: CE Turkey Issued on 29-04-2021

25,000/- Valid Till 27-05-2024
Challan No.
8331001977
261. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Ve Uretim VE Tubing Set Adult with Filter submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SD01151FP 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara SDC4440EN SDC4441EN Ce certificate. Also
C, 12th Turkiye SDC5441EN submit Fee slip and
Commercial SDC4331EN stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01-
Extension, 2022 Valid for 36 Months) Class B
Defence Fee Rs. 25000/-
Housing Turkey and EU Shelf Life 03 Years
Authority,
Karachi-75500, Letter of Authorization:
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:
Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025
Production Quality Assurance
Submission Certificate: Attached with Dossier
Detail: CE:

Amount: CE Turkey Issued on 29-04-2021

25,000/- Valid Till 27-05-2024
Challan No.
040952296457
262. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Saglik Malzemeleri Ve Uretim VE Multi Perfusion Set submission of the
Office No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SM00160SN 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara Ce certificate. Also
C, 12th Turkiye Class B submit Fee slip and
Commercial Fee Rs. 25000/- stability studies
Street, Phase FSC: FSC Turkey Issued on 14-01- Shelf Life 03 Years
II Extension, 2022 Valid for 36 Months)
Defence
Housing Turkey and EU
Authority,
Karachi- Letter of Authorization:
75500, Issued on 01-01-2022
Pakistan. Valid Till 31-12-2025
ELI-00237

Date of dossier ISO:

Submission: 05- ISO Turkey Issued on 02-02-2022

Valid Till 01-02-2025

Decisions of 85th Meeting of MDB (21-03-2025) Page 130 of 138

 04-2022 Fee
Production Quality Assurance
Certificate: Attached with Dossier
Submission
CE:
Detail:
CE Turkey Issued on 29-04-2021
Amount:
Valid Till 27-05-2024
25,000/-
Challan No.
9018711208
263. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Ve Uretim VE Aspiration Set submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SR00010SP 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara SR00060SP Ce certificate. Also
C, 12th Turkiye submit Fee slip and
Commercial Class B stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01- Fee Rs. 25000/-
Extension, 2022 Valid for 36 Months) Shelf Life 03 Years
Defence
Housing Turkey and EU
Authority,
Karachi-75500, Letter of Authorization:
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:
Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025
Production Quality Assurance
Submission Certificate: Attached with Dossier
Detail: CE:

Amount: CE Turkey Issued on 29-04-2021

25,000/-
Challan No. Valid Till 27-05-2024
0936426079
264. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Ve Uretim VE Blood Cardioplegia Set Adult submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SK00321HN 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara Ce certificate. Also
C, 12th Turkiye Class B submit Fee slip and
Commercial Fee Rs. 25000/- stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01- Shelf Life 03 Years
Extension, 2022 Valid for 36 Months)
Defence
Housing Turkey and EU
Authority,
Karachi-75500, Letter of Authorization:
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:

Decisions of 85th Meeting of MDB (21-03-2025) Page 131 of 138

 Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025

Submission Production Quality Assurance

Certificate: Attached with Dossier
Detail:
CE:
Amount:
CE Turkey Issued on 29-04-2021
25,000/-
Challan No. Valid Till 27-05-2024
434801506

265. M/S Medica Name of Legal Manufacturer: Sasan Sasan Medical Disposable Approved subject to
Address: Office Saglik Malzemeleri Uretim VE Hemofiltration Set submission of the
No. 1, Pazarlama A.S valid FSC, ISO
Mezzanine Address: Dagyaka Mah 2004 Cad. Codes/Sizes: SU0042SP 13485 and notarized
Floor, Plot No. No:6 Kahramankazan Ankara SU0011SP Ce certificate. Also
C, 12th Turkiye SU0051SP submit Fee slip and
Commercial stability studies
Street, Phase II FSC: FSC Turkey Issued on 14-01- Class B
Extension, 2022 Valid for 36 Months) Fee Rs. 25000/-
Defence Shelf Life 03 Years
Housing Turkey and EU
Authority,
Karachi-75500, Letter of Authorization:
Pakistan. Issued on 01-01-2022
ELI-00237 Valid Till 31-12-2025
Date of dossier
ISO:
Submission: 05-
ISO Turkey Issued on 02-02-2022
04-2022 Fee Valid Till 01-02-2025
Production Quality Assurance
Submission Certificate: Attached with Dossier
Detail: CE:

Amount: CE Turkey Issued on 29-04-2021

25,000/-
Valid Till 27-05-2024
Challan No.
268035088964
266. (ELI-00157) Molnlycke Health Care Biogel Approved Biogel
AB (Surgical Gloves) Surgeons subject to
Gamlestadsvagen 3C Class B submission of the
Box13080, SE-402 52 Shelf Life: 03 years stability studies.
Goteborg, Sweden Codes/Sizes: Apply separately for
Manufacturing Site: Biogel Surgeons (82255, the others and
Molnlycke Health 82260, 82265, 82270, submit Fee for the
Care Sdn Bhd, 82275, 82280, 82285, others
Malaysia 82290)
Date of R&I Biogel M
10-12-2024 (82355, 82360, 82365,
FSC: 82370, 82375, 82380,
Country of Origin 82380, 82390)
Issu date 13-02-2023 Biogel Super-Sensitive
LOA (82555, 82560, 82565,
Validity: 31-12-2025 82570, 82575, 82580,

Decisions of 85th Meeting of MDB (21-03-2025) Page 132 of 138

 ISO 13485 82585, 82590)
Validity: 27-11-2027 Biogel NeoDerm (42955,
42960, 42965, 42970,
42975, 42980, 42985,
42990)
Biogel Eclipse (75155,
75160, 75165, 75170,
75175, 75180, 75185,
75190) Biogel Eclipse
Indicator Underglove
(73255, 73260, 73265,
73270, 73275, 73280,
73285, 73290)
Biogel Eclipse Indicator
System (60755, 60760,
60765, 60770, 60775,
60780, 60785)
Biogel Skinsense (50955,
50960, 50965, 50970,
50975, 50980, 50985
50990)
Biogel Skinsense
Indicator Underglove
(40655, 40660, 40665,
40670, 40675, 40680,
40685, 40690)
Biogel Skinsense
Indicator System (28855,
28860, 28865, 28870,
28875, 28880, 28885)
Biogel PI Micro Indicator
(48555, 48560, 48565,
48570, 48575, 48580,
48585, 48590)
Biogel PI Micro Indicator
Underglove
(48955, 48960, 48965,
48970, 48975, 48980,
48985, 48990)
Biogel PI Micro Indicator
System (48355, 48360,
48365, 48370, 48375,
48380, 48385)
Biogel PI UltraTouch
(40955, 40960, 40965,
40970, 40975, 40980,
40985, 40990
Biogel PI Indicator
Underglove (41655, 41660,
41665, 41670, 41675,
41680, 41685, 41690)
Biogel PI Indicator
System (41455, 41460,
41465, 41470, 41475,
41480, 41485)
267. TRI-TECH Spencer Italia srl – located at Via EKO-S 60 Barella Autocaricante/ Approved subject to
INTERNATIO Provinciale, 12 - 43038 Self submission of the
NAL Sala Baganza PR – Italy Loading Stretcher R&I receiving and
FSC Italy issued 9.04.2024 . Code CA 80001 fee slip not

Decisions of 85th Meeting of MDB (21-03-2025) Page 133 of 138

 ISO valid till 04.8.2024 Class A submitted
Shelf life N/A letter attached
LAO valid till 25.08.2025

268. TRI-TECH Spencer Italia srl – located at Via EKO-S 68 Barella Autocaricante/ Approved subject to
INTERNATIO Provinciale, 12 - 43038 Self submission of the
NAL Sala Baganza PR – Italy Loading Stretcher R&I receiving and
FSC Italy issued 9.04.2024 . Code CA 80002 fee slip not
ISO valid till 04.8.2024 Class A submitted
Shelf life N/A
LAO valid till 25.08.2025

269. TRI-TECH Spencer Italia srl – located at Via EKO-MAX Approved subject to
INTERNATIO Provinciale, 12 - 43038 SISTEMA DI FISSAGGIO submission of the
NAL Sala Baganza PR – Italy R&I receiving and
FSC Italy issued 9.04.2024 . Code ST42723 fee slip not
ISO valid till 04.8.2024 Class A submitted
Service life 05 years
LAO valid till 25.08.2025

270. DIGITAL Legal Manufacturer: Dragonfly Opstar Imaging Catheter Approved

IMAGING
SYSTEMS M/s Abbott Medical, 4 Robbins 1014651
Road, Westford, MA 01886 USA
121 Habitat Class D
Apartments,
Shadman II, Manufacturing Site: Shelf life: 02 Years
Ghaus-ul-Azam M/s Abbott Medical, 4 Robbins
Road , Lahore- Road, Westford, MA 01886 USA
54000,
Pakistan,

Ph: 92-42-
35407151-53,
Fax: 92-42-
35407154

Licence no:
ELI-00094
Date of
Issuance: 03-
08-2018

271. M/s Kain Legal Manufacture: G-TEC Sclerotherapy Needles Approved

Medical, Ali
Bhai Center 3rd M/s Zhejiang Chuangxiang Medical Class B
Floor Office # Technology Co., Ltd., Room 101,
35 Main 201, 301, 401, 501, Building 50 Shelf life: 03 Years
Shahrah-e- No.650 Hongfeng Road Donghu
Qauideen, Street, Yuhang District, Hangzhou Codes/Sizes:
Karachi City, Zhejiang Province 311100, MD-A-SY-2423-2106
(ELI-00506) P.R. China MD-A-SY-2423-2306
MD-A-SY-2423-2506
FSC China valid till MD-A-SY-2418-2106
08-12-2026 MD-A-SY-2418-2306

Decisions of 85th Meeting of MDB (21-03-2025) Page 134 of 138

 MD-A-SY-2418-2506
ISO 13485 Valid Till
09-11-2026

CE Certification Valid till

23-07-2029
272. M/s ElectroMed Approved subject to
Legal Manufacture Brand Name: submission of fee as
Corporation
per revised SRO for
BRAEBON Medical Corporation, MediByte / MediByte Jr Family
1-100 Schneider Road, Kanata,
ELI-00163
Ontario, K2K 1Y2, Canada
(Generic Name):
R&I Details Manufacturing Site (s): Portable Sleep Data Recorders
13-03-2025 BRAEBON Medical Corporation,
1-100 Schneider Road, Kanata,
Class B
Ontario, K2K 1Y2, Canada
Fee Challan
No.
50980659747 LOA: Shelf life:
dated: 10-03-
Validity: 24-09-2029 04 Years
2025

FSC: Codes/Sizes:
Country of Origin MP8KN
Validity: 03-11-2029 MBJRK

EC Certificate:
Validity: 31-12-2028

ISO 13485:
Validity: 18-11-2027
273 M/s ElectroMed Approved subject to
Legal Manufacture Brand Name:
Corporation submission of fee as
BRAEBON Medical Corporation, Ultima Cannula per revised SRO for
1-100 Schneider Road, Kanata, Family
ELI-00163
Ontario, K2K 1Y2, Canada
(Generic Name):
R&I Details Manufacturing Site (s): Nasal Cannula for Sleep Recorders
13-03-2025 BRAEBON Medical Corporation,
1-100 Schneider Road, Kanata,
Class A
Ontario, K2K 1Y2, Canada
Fee Challan
No.
0115262623 FSC: Shelf life:
dated: 10-03-
Validity: 03-11-2029 05 Years
2025

LOA: Codes/Sizes:
Validity: 24-09-2029 0582
0582-50

Decisions of 85th Meeting of MDB (21-03-2025) Page 135 of 138

 0582PED
0582PED-50
0582S
0582S-50
0582S-F
0582S-F-50
0582S-3
0582S-3-50
0582S-7
0582S-7-50
5582
5582-40
8581
8581-50
8582
8582-50
8582PED
8582PED-50

LOCAL REGISTRATION/ENLISTMENT

Sr. No. Name & Address of Establishment Name of Medical Devices With Size Decision
1. Faiz Surgical and Medical industries ACCUJECT Auto-Disable Syringe Approved
pvt Ltd.
Plot No. 540-B Sundar Industrial Class: B
Estate, Lahore Shelf Life: 5 Years
(ELM-0093) Fee: 50000
[744-7L] Fee Slip No. 6572962470.
Sizes: ACCUJECT Auto-Disable Syringe 3ml
(With 23G,24G,25G,26G,
27G Needle), ACCUJECT Auto-Disable Syringe
5ml (With 23G,24G,25G,26G,
27G Needle)
2. Faiz Surgical and Medical industries ACCUSET Disposable Infusion Set Approved
pvt Ltd.
Plot No. 540-B Sundar Industrial Class: B
Estate, Lahore Shelf Life: 5 Years
(ELM-0093) Fee: 50000
[745-7L] Fee Slip No. 11602393831
Sizes: ACCUSET IV Set (Without Y-Port and
Filter), ACCUSET IV Set(With Y-Port and
Filter), ACCUSET IV Set(Luer Lock Connector
+ Bulb + Y-Port + Filter + Air Vent),
3. Faiz Surgical and Medical industries ACCUJECT Disposable Syringe Deferred for
pvt Ltd. confirmation
Plot No. 540-B Sundar Industrial Class: B manufacturing &
Estate, Lahore Shelf Life: 5 Years testing facility for the
(ELM-0093) applied product.
[746-7L] Sizes: ACCUJECT Disposable Syringe 1ml (With
27G Needle), ACCUJECT Disposable Syringe
1ml (With 21G Needle), ACCUJECT Disposable
Syringe 1ml (With 22G Needle), ACCUJECT
Disposable Syringe 1ml (With 23G Needle),

Decisions of 85th Meeting of MDB (21-03-2025) Page 136 of 138

 ACCUJECT Disposable Syringe 1ml (With 24G
Needle), ACCUJECT Disposable Syringe 1ml
(With 25G Needle), ACCUJECT Disposable
Syringe 1ml (With 26G Needle), ACCUJECT
Disposable Syringe U-100 (U-100 With 30G
Needle), ACCUJECT Disposable Syringe U-100
(U-100 With 31G Needle), ACCUJECT
Disposable Syringe 10ml (With 21G Needle),
ACCUJECT Disposable Syringe 10ml (With 22G
Needle), ACCUJECT Disposable Syringe 10ml
(With 23G Needle), ACCUJECT Disposable
Syringe 10ml (With 24G Needle), ACCUJECT
Disposable Syringe 10ml (With 25G Needle),
ACCUJECT Disposable Syringe 10ml (With 26G
Needle), ACCUJECT Disposable Syringe 20ml
(With 21G Needle), ACCUJECT Disposable
Syringe 30ml (With 21G Needle), ACCUJECT
Disposable Syringe 50ml (Catheter tip),
ACCUJECT Disposable Syringe 50ml (21G
Needle), ACCUJECT Disposable Syringe 60ml
(Catheter tip), ACCUJECT Disposable Syringe
60ml (With 21G Needle)

Fee: 50,000
Class: B
Shelf Life: 5 Years
Fee: 50000
Fee Slip No. 167436043
4. Faiz Surgical and Medical industries ACCUJECT Deferred the product
pvt Ltd. Hypodermic Syringe confirmation
Plot No. 540-B Sundar Industrial ACCUFLOW IV Cannula manufacturing &
Estate, Lahore ACCUJECT Butterfly testing facility for the
(ELM-0093) applied product.
[747-7L] Class: B Furthermore, only one
Shelf Life: 5 Years product ACCUJECT
Fee: 50000 Butterfly will be
Fee Slip No. 834392091518 considered in the
Sizes: ), ACCUJECT Butterfly (14G), current application.
ACCUJECT Butterfly (15G), ACCUJECT For the other two types
Butterfly (16G), ACCUJECT Butterfly (17G), the firm will have to
ACCUJECT Butterfly (18G), ACCUJECT submit Prescribed
Butterfly (19G), ACCUJECT Butterfly (20G), Form & fee.
ACCUJECT Butterfly (21G), ACCUJECT
Butterfly (22G), ACCUJECT Butterfly (23G),
ACCUJECT Butterfly (24G)
5. Faiz Surgical and Medical industries ACCUJECT Approved
pvt Ltd. Disposable Hypodermic Needle
Plot No. 540-B Sundar Industrial
Estate, Lahore Class: B
(ELM-0093) Shelf Life: 5 Years
[748-7L] Fee: 50000
Fee Slip No. 56335280
Sizes: Disposable Hypodermic Needle (18G),
ACCUJECT Disposable Hypodermic Needle
(20G) ACCUJECT Disposable Hypodermic
Needle (21G), ACCUJECT Disposable
Hypodermic Needle (22G), ACCUJECT
Disposable Hypodermic Needle (23G),
ACCUJECT Disposable Hypodermic Needle

Decisions of 85th Meeting of MDB (21-03-2025) Page 137 of 138

 (24G), ACCUJECT Disposable Hypodermic
Needle (25G), ACCUJECT Disposable
Hypodermic Needle (26G), ACCUJECT
Disposable Hypodermic Needle (27G),
ACCUJECT Disposable Hypodermic Needle
(30G), ACCUJECT Disposable Hypodermic
Needle (31G)

=============

Decisions of 85th Meeting of MDB (21-03-2025) Page 138 of 138