← Back to catalogue
PV and HB Combo Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref E11807Model 25 tests/box
Identity
- Trade Name
- PV and HB Combo Rapid Test Kit EUDAMED
- Device Name
- PV and HB Combo Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDE11807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581856 EUDAMED
- Basic UDI-DI
- 697518250E118072H EUDAMED
- Direct Marketing DI
- 06942293581856 EUDAMED
- EMDN Code
- W0105050209 PLASMODIUM (MALARIA) 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
PV and HB Combo 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 | 697518250E118072H | 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 c2e33d45-fb83-4012-a22a-c76e2c2279c9 61 fields · synced Oct 6, 2026