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Shoe Cover - EUDAMED Registration 26936662605735

Access comprehensive regulatory information for Shoe Cover 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 26936662605735 and manufactured by Kingstar Medical (Xianning) Co., LTD in China.

This page provides complete registration details including trade name (Shoe Cover), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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.

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EUDAMED Official Data
Class I
26936662605735
No
Shoe Cover
Trade Name: Shoe Cover
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Device Description (EMDN)

SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T0208
Trade Name
Shoe Cover
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
26936662605735
Basic UDI
6971872201351000N7
Version Date
February 08, 2025
Manufacturer Last Update
July 17, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 79 Yong'andong Road Xianning
Email
fan.rong@kingstarmedical.cn
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No