Vitalograph ALPHA Touch - 16 EU Declaration of Conformity

09100 Issue 1
33Page of 36
ENG
ALPHA Touch - Instructions for Use
16. EU Declaration of Conformity
Product: Model 6000 ALPHA Touch
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.
• Canadian Medical Device Regulation {SOR/98-282}
• FDA Quality System Regulation {QSR} 21 CFR 820.
• 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, CE 85553, MD 82182.
Signed on behalf of Vitalograph (Ireland) Ltd.
Frank Keane.
CEO, Vitalograph Ltd.