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EUDAMED registration 06977205529435No

Bone cutter

WILSON (Shanghai) Medical Device Co., Ltd. Class IIbEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
L090901
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06977205529435
Basic UDI
697720552BC0039C
Version date
January 24, 2025
Manufacturer last update
October 22, 2024
Active status
No
Manufacturer
Manufacturer name
WILSON (Shanghai) Medical Device Co., Ltd.
Country
China
Country type
NON_EU
Address
Area A, Floor 1, Building 8 and Area B, Floor 1, Building 3, No.868 Zhenchen Road, Baoshan District, Shanghai
Email
sunbo@wilsonprecisiontool.com
Authorized representative
Name
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
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)

BONE CUTTERS, REUSABLE

About this record

Access comprehensive regulatory information for Bone cutter in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06977205529435 and manufactured by WILSON (Shanghai) Medical Device Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.