Declaration of Conformity

For the following products:

Product Name: Digital Multi-channel Electrocardiograph

Model Designation: iMAC 120, iMAC 120pro

This is hereinafter confirmed to comply with the requirements set out in the Council Directive on the harmonization of the Laws of the Member States concerning Medical Device Directive (93/42/EEC As amended by 2007/47/EC).

The following standards have been met:

EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 15223-1:2016
EN 1041:2008
ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
IEC 60601-2-25:2011
EN 62304:2006/A1:2015
EN 62366-1:2015
EN 60601-1-6:2010/A1:2015
ETSI EN 300328 V2.2.2(2019-07)
ETSI EN301489-1 V2.2.3(2019-11)
Draft ETSI EN301489-17 V3.2.2(2019-12)
EN 62479:2010

Product Information:

Product Code:

GMDN Code: 16231
GMDN Term: Electrocardiograph, interpretive

Classification and Conformity Assessment Route:

Classification: IIa
Conformity Assessment Route: Annex II excluding section 4 of Medical Device Directive

Notified Body:

Name: DNV Product Assurance AS (NB No. 2460)

Address: Veritasveien 1, 1363 Høvik, Norway

European Representative:

The following representative in Europe is responsible for making this declaration:

Company Name: Well kang Limited
Company Address: Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland
Single Registration Number (SRN): XI-AR-000001836

Manufacturer Information:

The following manufacturer is responsible for making this declaration:

Company Name: Wuhan Zoncare Bio-medical Electronics Co., Ltd.
Company Address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan, Hubei, P.R. China
Single Registration Number (SRN): CN-MF-000010439

Signature: Qi Wang

Title: General Manager

Date: 2023-3-20

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