Appendix B - Interacoustics Aqua Stim Instructions D'utilisation

Aqua Stim Water Irrigator Instructions for Use - EN

Appendix B

Declaration of Conformity
Manufacturer:
CE Number:
Product model:
Classification:
Complies with:
Notified Body:
Compliance
Standards:
Manufactured for Interacoustics A/S
by Micromedical Technologies, Inc.
www.Interacoustics.com
500651
Aqua Stim
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
EN 60601-1-2:2007
EN 62304:2006
Basic safety and Essential Performance
Safety of Medical Electrical Systems
EMC Directive
Medical Device Software
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