Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)
- Risk class
- IVD General
- CND nomenclatures code
- W0105040502
- Trade name
- Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06955792733206
- Basic UDI
- B-06955792733206
- Version date
- March 05, 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
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
ENTEROVIRUS - NA REAGENTS
Access comprehensive regulatory information for Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing) 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 06955792733206 and manufactured by Sansure Biotech Inc. in China.
This page provides complete registration details including trade name (Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)), 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.