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DT_0006 Issue 15
A Global Leader in Respiratory Solutions
16. EU Declaration of Conformity
Product: 7100 VitaloJAK
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 classified 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 13485:2016 Medical devices. Quality management
systems. Requirements for regulatory purposes.
Certifying Body: British Standards Institute {BSI}.
BSI Notified Body #: 2797
Certificate Nos. CE 00772, MD 82182
Signed on behalf of Vitalograph (Ireland) Ltd.
Frank Keane.
CEO, Vitalograph Ltd.
Summary of Contents for VitaloJAK 7100
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