EUDAMED registration 06955792743441NoMonkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)
- Risk class
- IVD General
- CND nomenclatures code
- W0105900299
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06955792743441
- Basic UDI
- B-06955792743441
- Version date
- September 28, 2023
- 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
- OSEN
- SRN
- DE-AR-000023626
- Country
- Germany
- Address
- 18 Friedlebenstraße Frankfurt am Main
- wangsheng@osenn.de
- 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
- Yes
INFECTIOUS IMMUNOLOGY - OTHER
Access comprehensive regulatory information for Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay) 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 06955792743441 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.