Certificate No. 60148245

Certificate Number: 60148245
Certificate Holder: Cardiomatics Sp. z o.o.

ul. Wojciecha Weissa 7/C1
31-339 Kraków
Poland
Scope:

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

Fulfilled Standards: Richtlinie 93/42/EWG
Certificate Type: 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.