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Malaria P.f/Pan Antigen Combo Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref G11817Model 25 tests/boxRef G11831
Identity
- Trade Name
- Malaria P.f/Pan Antigen Combo Rapid Test Kit EUDAMEDMalaria P.f Antigen Rapid Test Kit EUDAMED
- Device Name
- Malaria P.f/Pan Antigen Combo Rapid Test Kit EUDAMEDMalaria P.f Antigen Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11817 EUDAMEDG11831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580972 EUDAMED06942293581771 EUDAMED
- Basic UDI-DI
- 697518250G118173E EUDAMED697518250G1183138 EUDAMED
- Direct Marketing DI
- 06942293580972 EUDAMED06942293581771 EUDAMED
- EMDN Code
- W0105050209 PLASMODIUM (MALARIA) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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/Pan Antigen 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 | 697518250G118173E | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 6fb6e214-d182-4b4b-b0dc-0fc13fe4b6ca 61 fields · synced Oct 6, 2026
- EUDAMED fc6b05cf-e50f-490b-99a8-f3e92cdffe85 61 fields · synced Aug 3, 2026