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Malaria P.f ＆P.v Rapid Test (Whole Blood)
EUDAMEDClass IVD General (EU MDR)
Ref CassetteRef MAL-4022a
Identity
- Trade Name
- Malaria P.f ＆P.v Rapid Test (Whole Blood) EUDAMEDMalaria P.f./P.v. Rapid Test (Whole Blood) EUDAMED
- Device Name
- Malaria P.f P.v Rapid Test EUDAMEDMalaria P.f./P.v. Rapid Test (Whole Blood) EUDAMED
- Model / Reference
- Cassette EUDAMEDMAL-4022a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977951 EUDAMEDD-697424646MAL003GRUS EUDAMED
- Basic UDI-DI
- B-06939663977951 EUDAMEDB-697424646MAL003GRUS 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
EUDAMEDEUDAMED
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 ＆P.v 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-06939663977951 | 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 (2)
- EUDAMED ee5cb755-545b-40d9-aae4-05432d2ac04f 61 fields · synced Jul 9, 2026
- EUDAMED 026e8bf6-8236-4191-a653-d2ccdb0b6d3e 61 fields · synced Jun 18, 2026