DeVilbiss UltraNeb - Declaration of Conformity

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Declaration of Conformity
Manufacturer: Wilfried Krömker GmbH
Address: Medizintechnik
Nordring 27 a
31675 Bückeburg - OT Röcke / Germany
Product Designation: Ultrasonic Nebulizer
Type, Model: UltraNeb
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: DIN EN IS0 13485:2007
Notified Body DQS Medizinprodukte GmbH
MDD Annex II applied
Safety Standards Applied: DIN EN ISO 13544:2007
EMC Compliance to: IEC 60601-1-2:2007
CISPR 11/EN55011
Place: Bückeburg
Signature:
Name: i� A� Julia Grunwald – Quality Manager
European Distribution: DeVilbiss Healthcare GmbH
Kamenzer Strasse
368309 Mannheim
Germany
Phone + 49 (0) 6 21 / 1 78 98 - 0
Fax + 49 (0) 6 21 / 1 78 98 -220
www�devilbisshc�com
kontakt@devilbisshc�com
® Registered U�S� Patent and Trademark Office and other countries�
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