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Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SC20204W-20TRef SC20204W-25T
Identity
- Trade Name
- Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit EUDAMED
- Device Name
- Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit EUDAMED
- Model / Reference
- SC20204W-20T EUDAMEDSC20204W-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SC20204W-20TWQ EUDAMEDD-SC20204W-25TX7 EUDAMED
- Basic UDI-DI
- B-SC20204W-20TWQ EUDAMEDB-SC20204W-25TX7 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
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-SC20204W-20TWQ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 34354ff6-5100-49e1-95d6-77ae8f332c07 61 fields · synced Jul 30, 2026
- EUDAMED d30d61cb-7213-417d-ba23-ff31410567e7 61 fields · synced May 18, 2026