Dengue NS1 Rapid Test
- Risk class
- Class C
- CND nomenclatures code
- W0105099007
- Trade name
- Dengue NS1 Rapid Test (AchieveDx Brand)
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06936983172318
- Basic UDI
- 6970277510001AXE
- Version date
- December 19, 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
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Italy
- Market available
- Italy:2024-05-23~2027-07-12
- Human tissues
- No
- Animal tissues
- Yes
DENGUE - RT & POC
Access comprehensive regulatory information for Dengue NS1 Rapid Test 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 06936983172318 and manufactured by Hangzhou Alltest Biotech.Co.,Ltd. in China.
This page provides complete registration details including trade name (Dengue NS1 Rapid Test (AchieveDx Brand)), 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.