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
|
| Fulfilled Standards: |
Richtlinie 93/42/EWG
|
| Certificate Type: |
Vollst. QMS, Anhang II MDD
EC declaration of conformity (Full quality assurance system) 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. |