Declaration of Conformity

Product Details

Product Name: Digital Multi-channel Electrocardiograph

Model Designation: iMAC 300, iMAC 300pro

Product Code: GMDN Code: 16231

GMDN Term: Electrocardiograph, interpretive

Compliance Statement

This document confirms compliance 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).

Applicable Standards

EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 15223-1:2016
ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010
EN 1041:2008
EN 60601-1:2006/A1:2013
IEC 60601-2-25:2011
EN 60601-1-2:2015
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

Classification and Conformity Assessment Route

Classification: IIa

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

Notified Body

DNV Product Assurance AS (NB No. 2460)

Veritasveien 1, 1363 Høvik, Norway

European Representative

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

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

Authorization

Signed by: Qi Wang

Position: General Manager

Date: 2023-3-20

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