EUDAMED registration 06976374330378NoHC-20F
Zenith Lab (Jiangsu) Co.,LtdClass AEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
- Risk class
- Class A
- CND nomenclatures code
- W02069003
- Implantable
- No
- Reusable
- No
- Measuring function
- No
Registration information
- Primary DI
- 06976374330378
- Basic UDI
- 697637433HC-20FCN
- Version date
- July 31, 2024
- Manufacturer last update
- July 28, 2022
- Active status
- No
Manufacturer
- Manufacturer name
- Zenith Lab (Jiangsu) Co.,Ltd
- Country
- China
- Country type
- NON_EU
- Address
- NO.12 NO.12,Hongshan Road,Jincheng industrial area,Jintan district Changzhou
- service@labzj.com
Authorized representative
- SRN
- NL-AR-000000444
- Country
- Netherlands
- Address
- Treubstraat 1 Rijswijk
- ar@umedwings.eu
- Telephone
- +31 (0) 642758955
Regulatory information
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Germany
Device characteristics
- Human tissues
- No
- Animal tissues
- No
Device description (EMDN)
CENTRIFUGES
About this record
Access comprehensive regulatory information for HC-20F in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06976374330378 and manufactured by Zenith Lab (Jiangsu) 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.