EUDAMED registration 06971390439685NoHOKAPI™ NSE
- Risk class
- IVD General
- CND nomenclatures code
- W0102039007
- Trade name
- HOKAPI™ NSE
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06971390439685
- Basic UDI
- B-06971390439685
- Version date
- October 08, 2022
- Manufacturer last update
- November 08, 2021
- Active status
- No
- Manufacturer name
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- Country
- China
- Country type
- NON_EU
- Address
- Building 4, No.8, Jinfeng Road, Science & Technology Park, High Tech New District Suzhou
- zhuzhenrong@hybiome.com
- SRN
- DE-AR-000000001
- Country
- Germany
- Address
- 80 Eiffestraße Hamburg
- shholding@hotmail.com
- Telephone
- +49 40 2513175
- 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
- Human tissues
- No
- Animal tissues
- Yes
NEURON SPECIFIC ENOLASE
Access comprehensive regulatory information for HOKAPI™ NSE 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 06971390439685 and manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd.. in China.
This page provides complete registration details including trade name (HOKAPI™ NSE), 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.