Vitalograph Compact User Manual

09220 Issue 2
23Page of 28
ENG
Vitalograph COMPACT - Instructions for Use
17. EU Declaration of Conformity
Product: 6600 Vitalograph Compact
Vitalograph hereby ensures and declares that the above product associated
with these instructions for use, is designed and manufactured in accordance
with the following QMS regulations and standards:
• European Medical Devices Directive {MDD} 93/42/EEC, as amended.
ThisdeviceisclassiedasIIaperAnnexIXoftheMDDalso
meets the provisions of the Essential Requirements, Annex
I, via compliance with Annex II of the Medical Devices
Directive as per Article 11, section 3a, excluding point 4 of
Annex II.
• EN ISO 13485 Medical devices. Quality management systems.
Requirements for regulatory purposes.
Certifying Body: British Standards Institute {BSI}.
BSINotiedBody#:2797
CerticateNos.CE00772,MD82182
Signed on behalf of Vitalograph (Ireland) Ltd.
Frank Keane.
CEO, Vitalograph Ltd.

Vitalograph Compact Specifications

General

Brand	Vitalograph
Model	Compact
Category	Medical Equipment
Language	English