Appendix B - Interacoustics Air Fx Mode D'emploi

Air Fx Irrigator Instructions for Use - EN

Appendix B

Declaration of Conformity
Manufacturer:
Technologies, Inc.
CE Number:
Product model:
Classification:
Complies with:
Notified Body:
Compliance
Standards:
European
Representative:
Company
Representative:
Manufactured for Interacoustics A/S by Micromedical
10 Kemp Drive
Chatham, IL 62629
Tel: 217-483-2122
Fax: 217-483-2122
www.micromedical.com
500651
Air Fx
IIa according to MDD 93/42/EEC Annex IX, rule 10
Annex V of the Medical Device Directive 93/42/EEC
as amended by Directive 2007/47/EC
BSI Management Systems CE 0086
EN 60601-1:2006
EN 60601-1-1:2001 Safety of Medical Electrical Systems
EN 60601-1-2:2007 EMC Directive
EN 62304:2006
Mr. Martin Lindon-Jones
Guymark UK
St. Luke's House
Upper High Street
Cradley Heath
West Midlands
B64 5HX
United Kingdom
Richard Miles
Responsible contact
Title: CEO
Email: rick@Micromedical.com
USA
Basic safety and Essential Performance
Medical Device Software
Telephone:
FAX:
email:
Page
+44-1384-410-848
+44-1384-410-898
martin@guymark.com
27