GE Healthcare
EU DECLARATION OF CONFORMITY
Following the provisions of the medical devices regulation 2017/745,
ROHS directive 2011/65/EU and Radio Equipment Directive 2014/53/EU.
We:
Manufacturer EU Authorized Representative
GE Medical Systems Information Technologies, Inc. GE Medical Systems SCS
9900 Innovation Drive 283 rue de la Minière
Wauwatosa, WI 53226, USA 78530 BUC, France
Single Registration Number (SRN): US-MF-000017529 SRN: FR-AR-000000344
Manufacturing Site
GE Medical systems (China) Co., Ltd.
No. 19, ChangJiang Road, WuXi National Hi-tech Development Zone
Jiangsu, P.R. China 214028
GE Medical Systems Information Technologies
Critikon de Mexico S. de R.L. de C.V.
Calle Valle del cedro 1551
Juarez 32575 Chihuahua Mexico
Wipro GE Medical Device Manufacturing Private Limited
No. 4, Kadugodi Industrial Area, Sadarmangala, Whitefield
Bangalore, Karnataka, India, 560067
Declare under our sole responsibility that the device:
B125P/B105P/B125M/B105M/B155M Patient Monitor
Basic UDI-DI: 8406821BUG00102GM
Identification number:
SIGNATURE:
Date: 2022.06.09
10:35:44 +02'00'
__________________________ _09 June 2022______
Jung, William Date
Regulatory Affairs Director – Monitoring Solutions
Virginia, USA
Page 1 of 2 Reference of the Declaration: DOC2430297
GE Healthcare
B105P 6160000-001
B125P 6160000-002
B105M 6160000-003
B125M 6160000-004
B155M 6160000-005
Intended Purpose: Vital Signs Monitoring Instrument
GMDN Code and Description: 33586 Patient monitor, multiparameter
EMDN Code and Description: Z120302 Vital Signs Monitoring Instruments
Class: IIb
Classification rule (Annex VIII): Rule 10
To which this declaration relates is in conformity with the requirements of the medical devices regulation 2017/745
that apply to it and with the requirements of the RoHS directive 2011/65/EU on the restriction of the use of certain
hazardous substances in electrical and electronic equipment.
This conformity is based on the following elements:
Technical Documentation reference: DOC2430158, of the product to which this declaration relates.
EC certificate No. HZ 2214580-1:
Conformity assessment procedure followed: Annex IX, Chapters I, III
Delivered by TÜV Rheinland LGA Products GmbH (0197)
We, manufacturer, declare under our sole responsibility that:
B125P/B105P/B125M/B105M/B155M Patient Monitor equipped with B1x5-01 WLAN module
To which this declaration relates is in conformity with the requirements of the Radio Equipment Directive
2014/53/EU which applies to it.
This conformity is based on the following elements:
- The device conforms to the Directive 2014/53/EU through Annex II-Internal Production Control
- The list of harmonized standards applied is located in the Technical File for this product.
SIGNATURE:
Date: 2022.06.09
10:40:56 +02'00'
__________________________ _09 June 2022______
Jung, William Date
Regulatory Affairs Director – Monitoring Solutions
Virginia, USA
Page 2 of 2 Reference of the Declaration: DOC2430297
