EC Declaration of Conformity
BT/CE-04-2014  (A/0)
Page  1/1 EC Declaration of Conformity
Manufacturer :
whose single Authorized Representative:
XXXXXXXXXXXX CO.,LTD
XXXXXXXXXXXXXXXXXXXXX
We, the manufacturer, herewith declare that the products  DISPOSABLE STERILE RETRACTABLE SAFETY SYRINGE    UMDNS -Code: 12132; GMDN-Code/Preferred Terms: XXXXX
meet the provisions of Directive 93/42/EEC which apply to them.
The medical device has been assigned to class  IIa  according to Annex IX of the Directive 93/42/EEC. It bears the mark
0197
The product concerned has been and  manufactured under a quality management system according to Annex V  of Directive 93/42/EEC.
Compliance of the designated product with the Directive 93/42/EEC has been assessed and certified by the Notified Body
TÜV Rheinland LGA Products GmbH
Tillystraße 2, 90431, Nürnberg, Germany
Certificate No.: xxxxxxxxx
Issue date: xxxxxxxxx
Expiry date: xxxxxxxxxretractable
following the procedure relating to the EC Declaration of Conformity set out in  Annex V of Directive 93/42/EEC.
This Declaration of Conformity covers all medical devices as specified in the product list belonging to this declaration and is only valid in connection with a batch specific Certificate of Compliance for all products concerned bearing the CE mark
The above mentioned declaration of conformity is exclusively under the responsibility of
Company: XXXXXXXXXXXXXXXX
Address: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Place, date        Legally binding signature, Function

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