证书号 60148245

证书号码: 60148245
证书持有人: Cardiomatics Sp. z o.o.

ul. Wojciecha Weissa 7/C1
31-339 Kraków
波兰
范围:

Standalone software for ECG signal analysis
Replaces EC Certificate, Registration No.: HD 60129514 0001

测试标准: Richtlinie 93/42/EWG
证书类型: Vollst. QMS, Anhang II MDD

EC declaration of conformity (Full quality assurance system)
Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

This approval can be used by the company in line with the declaration of conformity.