Strep A Antigen Rapid Test (Immunochromatography)
- Risk class
- IVD General
- CND nomenclatures code
- W0105090103
- Trade name
- Strep A Antigen Rapid Test (Immunochromatography)
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06935091672017
- Basic UDI
- B-06935091672017
- Active status
- No
- Manufacturer name
- Qingdao Hightop Biotech Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No.369 Hedong Road Qingdao, Shandong
- registered@hightopqd.com
- 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
- Croatia
- Human tissues
- No
- Animal tissues
- No
STREP. A - RT & POC
Access comprehensive regulatory information for Strep A Antigen Rapid Test (Immunochromatography) 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 06935091672017 and manufactured by Qingdao Hightop Biotech Co., Ltd. in China.
This page provides complete registration details including trade name (Strep A Antigen Rapid Test (Immunochromatography)), 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.