H.pylori Antigen Rapid Test Cassette
- Risk class
- IVD devices for self-testing
- CND nomenclatures code
- W0105090102
- Trade name
- H.pylori Antigen Rapid Test Cassette
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06936983152662
- Basic UDI
- B-06936983152662
- Version date
- December 31, 2024
- Manufacturer last update
- November 11, 2024
- Active status
- No
- Manufacturer name
- Hangzhou Alltest Biotech.Co.,Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- #550 Yinhai Street Hangzhou
- info@alltests.com.cn
- SRN
- DE-AR-000000002
- Country
- Germany
- Address
- 10 Borkstrasse Münster
- ecrep@medneteurope.com
- Telephone
- +49 251 322 66 64
- Competent authority
- DE/CA22 - Bezirksregierung Münster
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Austria
- Human tissues
- No
- Animal tissues
- Yes
H. PYLORI - RT & POC
Access comprehensive regulatory information for H.pylori Antigen Rapid Test Cassette in the European Union medical device market through Pure Global AI's free database. This IVD devices for self-testing device is registered with EU EUDAMED under Primary DI 06936983152662 and manufactured by Hangzhou Alltest Biotech.Co.,Ltd. in China.
This page provides complete registration details including trade name (H.pylori Antigen Rapid Test Cassette), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.