Declaration of Conformity
Manufacturer:
Address:
Product Designation:
Type, Model:
We herewith declare that the above-mentioned product complies with the requirements
of EC Directive 93/42/EEC and the following:
Quality System Standards Applied:
Notified Body
MDD Annex II Applied
Safety Standards Applied:
EMC Compliance to:
Place:
Signature:
Name:
European Contact:
® Registered U.S. Patent and Trademark Office and other countries.
Wilfried Krömker GmbH
Medizintechnik
Nordring 27 a
31675 Bückeburg - OT Röcke / Germany
Ultrasonic Nebulizer
UltraNeb
DIN EN IS0 9001 / DIN EN IS0 13485
DQS
IEC 60601-1:1998 +A1:1991 +A2:1995
IEC 60601-1-2:2001
CISPR 11/EN55011
Bückeburg
i. A. Ullrich Hanisch – Quality Manager
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
English
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