6.Attachment 12 Declaration of Conformity

DECLARATION OF CONFORMITY

DANYANG COMED HEALTHCARE CO.，LTD.

Name and address of the firm

Address：No.3, BeiErHuan Road, Danyang City, Jiangsu Province, China

We declare under our sole responsibility that

Transport wheelchair

the medical device

CM401A，CM401B

Name, type or model, batch or serial number, possibly sources and number of items

of class

meets all the provisions of the directive 93/42/EEC (or 90/385/EEC) which apply to it.

I

according to annex IX of direct. 93/42/EEC

ISO 13485:2003 EN 980 EN 1041

Applied harmonised standards, national standards or other normative documents

BS EN 1985 EN ISO 11199-2 EN ISO 9999 EN ISO 14155-1 EN ISO 14155-2 EN ISO 14971

Conformity assessment procedure

ANNEX Ⅶ

EC DECLARATION OF CONFORMITY

Notified Body (if consulted)

Place, date

Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg, Germany

General manager