EUDAMED registration 06974222260648NoSperm DNA Fragmentation Detection Kit (Sperm Chromatin Dispersion Method)
- Risk class
- Class A
- CND nomenclatures code
- W01030708
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06974222260648
- Basic UDI
- 697422226019GX
- Active status
- No
- Manufacturer name
- Zhuhai Cariad Medical Technology Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- 5/F, Block 6, No.6 Jinyuan 1st Rd., High-tech Zone, 519085 Zhuhai, Guangdong, P. R. China Zhuhai
- support@cariad.com.cn
- Name
- PureCE B.V.
- SRN
- NL-AR-000006069
- Country
- Netherlands
- Address
- 13 Distriebutieweg Waddinxveen
- info@purece.nl
- Telephone
- +31 10 899 0449
- 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
- Greece
- Market available
- Czechia:2024-03-21~2024-03-22, Greece:2024-03-21~2024-09-26
- Human tissues
- No
- Animal tissues
- No
STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
Access comprehensive regulatory information for Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Dispersion Method) 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 06974222260648 and manufactured by Zhuhai Cariad Medical Technology 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.