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Malaria P.f Antibody Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref G11832Model 25 tests/box
Identity
- Device Name
- Malaria P.f Antibody Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11832 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581788 EUDAMED
- Basic UDI-DI
- 697518250G118323A EUDAMED
- Direct Marketing DI
- 06942293581788 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
Malaria P.f Antibody 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 | 697518250G118323A | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3742c248-650e-402f-a932-216eeb30d41c 61 fields · synced Jul 14, 2026