Declaration of Conformity

For the following products:

Digital Multi-channel Electrocardiograph

(Product Name)

iMAC 12, iMAC 12pro

(Model Designation)

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)

Standards Compliance:

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

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:

DNV Product Assurance AS (NB No. 2460)

Veritasveien 1, 1363 Hvik, Norway

European Representative:

Well kang Limited Company

Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland

Single Registration Number (SRN): XI-AR-000001836

Manufacturer:

Wuhan Zoncare Bio-medical Electronics Co., Ltd.

#380, High-tech 2nd road, Eastlake high-tech district, Wuhan, Hubei, P. R. China

Single Registration Number (SRN): CN-MF-000010439

________________ (Legal Signature)

General Manager

(Position/title)

________________ (Date)

2023-3-20

	Zoncare iMAC 300/300pro Declaration of Conformity - Digital Electrocardiograph Official Declaration of Conformity for the Zoncare iMAC 300 and iMAC 300pro Digital Multi-channel Electrocardiograph, confirming adherence to the Medical Device Directive and relevant international standards.
	Digital Multi-Channel Electrocardiograph iMAC 300/300pro User Manual User manual for the Wuhan Zoncare Digital Multi-Channel Electrocardiograph, models iMAC 300 and iMAC 300pro. Covers installation, operation, maintenance, safety, and troubleshooting.
	Declaration of Conformity for iMAC 120 and iMAC 120pro Electrocardiographs This document is a Declaration of Conformity for the iMAC 120 and iMAC 120pro Digital Multi-channel Electrocardiographs, confirming compliance with the Medical Device Directive (93/42/EEC). It details product information, relevant standards, notified body, European representative, and manufacturer.
	Zoncare iMAC 120/120pro ECG Machine User Manual Comprehensive user manual for the Zoncare iMAC 120 and iMAC 120pro Digital Multi-Channel Electrocardiograph Machine, covering installation, operation, maintenance, and troubleshooting.
	Zoncare iMAC 12pro Tablet ECG Machine Datasheet Datasheet for the Zoncare iMAC 12pro Tablet ECG Machine, detailing its features, functions, technical specifications, standard accessories, optional components, and adherence to standards.
	Zoncare iMAC 300pro 3-Ch ECG Machine Datasheet - Specifications and Features Detailed datasheet for the Zoncare iMAC 300pro 3-Channel ECG Machine, covering features, technical specifications, functions, standard and optional accessories, and adherence to standards. Includes information on sampling, recording, analysis, and connectivity.
	Zoncare iMAC 12pro Tablet ECG Machine: Features, Performance, and Connectivity Discover the Zoncare iMAC 12pro, a Reddot Design Award-winning tablet ECG machine. Learn about its ergonomic design, advanced performance features like 12-lead synchronous acquisition and the Glasgow Algorithm, and seamless connectivity options for healthcare environments.
	Zoncare iMAC 120 Classic 12-Channel ECG Machine - Features and Performance Discover the Zoncare iMAC 120, a classic 12-channel ECG machine. This document details its ergonomic design, advanced performance powered by the Glasgow Algorithm, versatile connectivity options, and efficient report management for clinical environments.