Declaration of Conformity

Changzhou Waston Medical Appliance Co., Ltd.

Manufacturer:
No.9 Xihu Road, Wujin Hi-Tech Industry Zone, 213164 Changzhou, Jiangsu, China
European Shanghai International Holding Corp. GmbH (Europe)
Representative : Eiffestrasses 80, 20537 Hamburg, Germany
Product Name: Trauma System Instruments Sets,Intramedullary Nails Instruments Sets,
Spinal System Instruments Sets, Thoracic System Instruments Sets
Model Number: Please refer to the annexed product list.
UMDNS Code: 12833
Classification: (MDD Annex IX): Ⅰ, rule 6
Conformity Assessment Route: Annex Ⅶ
We herewith declare that the above mentioned products meet the transposition into national law,
the provisions of the following EC Council Directives and Standards. All supporting
documentations are retained under the premises of the manufacturer.
Changzhou Waston Medical Appliance Co., Ltd is exclusively responsible for the declaration of
conformity.
DIRECTIVES
General applicable directives :
Medical Device Directive : COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical
devices (MDD 93/42/EEC).
Place, Date and Issue: Changzhou, 2021-05-21

Signature:

Name: Zhou Hua

Position: Management Representative