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LooK SPOT CE IVD Notification Certificate 2021

This document is a certificate of notification from Obelis s.a., the European Authorized Representative, to Laipac Technology Inc. It certifies that Obelis completed all notification duties for two Laipac in-vitro diagnostic medical devices to the appropriate authorities in the EU. The devices, a smartphone reader for a COVID-19 antigen rapid test and a COVID-19 antigen rapid test kit, are now allowed to be marketed and sold in Belgium and other EU/EEA countries with the proper labeling as long as Laipac maintains compliance with regulatory requirements.

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82 views2 pages

LooK SPOT CE IVD Notification Certificate 2021

This document is a certificate of notification from Obelis s.a., the European Authorized Representative, to Laipac Technology Inc. It certifies that Obelis completed all notification duties for two Laipac in-vitro diagnostic medical devices to the appropriate authorities in the EU. The devices, a smartphone reader for a COVID-19 antigen rapid test and a COVID-19 antigen rapid test kit, are now allowed to be marketed and sold in Belgium and other EU/EEA countries with the proper labeling as long as Laipac maintains compliance with regulatory requirements.

Uploaded by

luis
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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ONSIBLE

SP P
RE

ER
EUROPEAN

SO
N CENTER
OF
CERTIFICATE
IVD NOTIFICATION
Ref. No.:FG 0571-2021
Belgium Date: 18/01/2021
Order No.:OG 0416-2020N

This is to certify that, according to the Council Directive 98/79/EC, Obelis s.a. (O.E.A.R.C.)
performed all notification duties and responsibilities as the European Authorized
Representative (EC REP) of:

name: LAIPAC TECHNOLOGY INC.

Address: 20 Mural St.Unit 5, Richmond Hill Ontario L4B 1K3


Canada

as stipulated and demanded by the aforementioned directive.

The Manufacturer declares that the IVD devices comply with the Directive including all essential requirements.

The Manufacturer has provided Obelis s.a. (O.E.A.R.C.) with all the appropriate declarations according to the 98/79/EC
Directive – article 10 requirements including the EC Declaration of Conformity confirming that his In-Vitro Diagnostics
medical devices, as stipulated here above, are fulfilling the applicable requirements of the European Council Directive
98/79/EC

The notification of the following In-Vitro Diagnostic medical devices has been completed by Obelis s.a. (O.E.A.R.C.) on
the 15/01/2021 in compliance with the European Council Directive 98/79/EC - article 10 requirements.

In-vitro diagnostic medical device: Please See Annex A - List of Devices ( 1 page, 2 Devices)

As of the 16/01/2021, and as long as the manufacturer will continue complying with the hereabove mentioned
requirements* he therefore:

- Is required to affix the CE marking on these devices;

- Place these devices in the Territory of Belgium and/or the other EEA Member States (excluding territories not in
alignment with Decision 2010/227/EU).

Mr. G. Elkayam CEO


Obelis sa
Obelis European Authorized Representative Center is a member of the European Association of
Authorized Representatives (E.A.A.R.), ISO 9001 : 2015 and ISO 13485 : 2016 certified in
accordance to the profession of a European Authorized Representative.
* This is not a CE mark and is only provided
as a template for informational purposes.

** This Certificate will be automatically void if the notification is rejected by the EU Authorities or upon termination of the EAR
agreement.

Registered Address : Bd. Général Wahis 53 - 1030 Brussels I Registered Office Address : Bd Brand Whitlock 30, B-1200 Brussels - Belgium
T: + 32 (0) 2 732 5954 I F: + 32 (0) 2 732 6003 I Email: [email protected] I Website: www.obelis.net
V3 - ID: 00454716 - 22/02/2019
1 of 1

Order No.: OG 0416-2020N


Ref No.: FG 0571-2021

Annex A - List of Devices


(Recital 29 of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices)
Catalogue
Commercial Short description and intended GMDN/
# reference Generic Device Term Class
Name use EDMS Code
number
A smartphone based reader
COVID-19 Antigen
1. 105A LooK SPOT for COVID-19 Antigen Rapid 21.07.10.09 All others
Rapid Test Reader
Test

A LFA assay intended for the


qualitative detection of
LooK COVID-19 nucleocapsid protein from
COVID-19 Antigen
2. 105B Antigen Rapid SARS-CoV-2 in nasal swabs 15.04.09.01 All Others
Rapid Test Kit
Test from patients suspected of
COVID-19 within the first eight
(8) days of symptom onset.

M e Obelis s.a.

____ Signature:

_____
Stamp:

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