EUDAMED registration 06971042225161NoCryptococcus Neoformans Real Time PCR Kit
- Risk class
- IVD General
- CND nomenclatures code
- W0105060499
- Trade name
- Cryptococcus Neoformans Real Time PCR Kit
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06971042225161
- Basic UDI
- B-06971042225161
- Version date
- October 18, 2024
- Manufacturer last update
- September 01, 2022
- Active status
- No
- Manufacturer name
- SHANGHAI ZJ BIO-TECH CO., LTD
- Country
- China
- Country type
- NON_EU
- Address
- 528 Ruiqing Road No. 20 and 21 Building, 528 Ruiqing Road, Zhangjiang High-tech Industrial East District Shanghai
- registration@liferiver.com.cn
- SRN
- ES-AR-000001202
- Country
- Spain
- Address
- 55 Calle de Almansa Madrid
- leis@riomavix.com
- 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
MYCOLOGY NA REAGENTS - OTHER
Access comprehensive regulatory information for Cryptococcus Neoformans Real Time PCR Kit 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 06971042225161 and manufactured by SHANGHAI ZJ BIO-TECH CO., LTD in China.
This page provides complete registration details including trade name (Cryptococcus Neoformans Real Time PCR Kit), 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.