Certificado nº 60148245
| Número de Certificado: | 60148245 |
| Certificado Titular: |
Cardiomatics Sp. z o.o. ul. Wojciecha Weissa 7/C1 31-339 Kraków Polonia |
| Alcance de la Certificación: |
Standalone software for ECG signal analysis
|
| Estándares cumplidos: |
Richtlinie 93/42/EWG
|
| Tipo de Certificado: |
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. |