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HOKAPI™ TSH - EUDAMED Registration 06971390434864

Access comprehensive regulatory information for HOKAPI™ TSH in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06971390434864 and manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd.. in China.

This page provides complete registration details including trade name (HOKAPI™ TSH), 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
IVD General
06971390434864
No
HOKAPI™ TSH
Trade Name: HOKAPI™ TSH
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Device Description (EMDN)

THYROID STIMULATING HORMONE

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W01020410
Trade Name
HOKAPI™ TSH
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971390434864
Basic UDI
B-06971390434864
Version Date
August 26, 2022
Manufacturer Last Update
November 08, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 4, No.8, Jinfeng Road, Science & Technology Park, High Tech New District Suzhou
Email
zhuzhenrong@hybiome.com
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
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
France
Device Characteristics
Human Tissues
Yes
Animal Tissues
Yes