← Back to catalogue
Group B Streptococcus Antigen Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref L11810Model 25 tests/box
Identity
- Trade Name
- Group B Streptococcus Antigen Rapid Test Kit EUDAMED
- Device Name
- Group B Streptococcus Antigen Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDL11810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581832 EUDAMED
- Basic UDI-DI
- 697518250L118104Z EUDAMED
- Direct Marketing DI
- 06942293581832 EUDAMED
- EMDN Code
- W0105011101 STREPTOCOCCAL DIRECT ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Group B Streptococcus Antigen Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250L118104Z | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 0ef989c1-7dba-4ec8-8022-4e9076bacda6 61 fields · synced Jun 19, 2026