Certificado nº 60149031

Número de Certificado: 60149031
Certificado Titular: VacuTec Meßtechnik GmbH

Dornblüthstr. 14 a
01277 Dresden
Alemania
Alcance de la Certificación:

Detectors and systems for the detection and measurement of
ionizing radiation
(see attachment for products included)
Replaces Certificate, Registration No.: HD 60127716 0001
Products included:
- Ionization chambers for automatic X-ray exposure control
For the following devices the scope covers only
the aspects of manufacture concerned with conformity
of the products with the metrological requirements:
- Dose area product meters

Estándares cumplidos: Richtlinie 93/42/EWG
Tipo de Certificado: 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.