Pure Global AI
EUDAMED registration 06974775888153Yes

Active Wheelchair Manual Wheelchair

Shanghai Wisking Electric Machine Co.,Ltd.Class IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y122103
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06974775888153
Basic UDI
697477588MWheelchair29
Active status
Yes
Manufacturer
Manufacturer name
Shanghai Wisking Electric Machine Co.,Ltd.
Country
China
Country type
NON_EU
Address
N0.168 Pinggang Road,Situan Town,Fengxian District, Shanghai
Email
Ww5668@126.com
Authorized representative
Name
Sungo Cert GmbH
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Düsseldorf
Email
de.rep@sungoglobal.com
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Austria
Market available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PUSH WHEELCHAIRS

About this record

Access comprehensive regulatory information for Active Wheelchair Manual Wheelchair in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06974775888153 and manufactured by Shanghai Wisking Electric Machine Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.