Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
- Risk class
- Class C
- CND nomenclatures code
- W0105011104
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06955792700895
- Basic UDI
- 69557927S3056E000001S7
- Version date
- January 08, 2025
- Manufacturer last update
- June 07, 2023
- Active status
- No
- Manufacturer name
- Sansure Biotech Inc.
- Country
- China
- Country type
- NON_EU
- Address
- No.680 Lusong Road, Yuelu District Changsha, Hunan Province
- info@sansure.com.cn
- Name
- Obelis s.a.
- SRN
- BE-AR-000000106
- Country
- Belgium
- Address
- 53 Boulevard Général Wahis Brussels
- regulatory@obelis.net
- Telephone
- +32(2)73 25 954
- Competent authority
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- France
- Market available
- France:2024-11-28~None
- Human tissues
- No
- Animal tissues
- No
STREP. B DETECTION BY NA REAGENTS
Access comprehensive regulatory information for Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) in the European Union medical device market through Pure Global AI's free database. This Class C device is registered with EU EUDAMED under Primary DI 06955792700895 and manufactured by Sansure Biotech Inc. in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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.