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Malaria P.f ＆Pan Rapid Test (whole blood)
EUDAMEDClass IVD General (EU MDR)
Ref Cassette
Identity
- Trade Name
- Malaria P.f ＆Pan Rapid Test (whole blood) EUDAMED
- Device Name
- Malaria P.f Pan Rapid Test EUDAMED
- Model / Reference
- Cassette EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977944 EUDAMED
- Basic UDI-DI
- B-06939663977944 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Malaria P.f ＆Pan Rapid Test (whole blood) by Sejoy Biomedical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06939663977944 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 52f8dcb9-6e6c-42d9-ba6b-6ddec2a55155 61 fields · synced Jun 19, 2026