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Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SC20203W-50TRef SC20203W-1TRef SC20203W-20T
Identity
- Trade Name
- Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit EUDAMED
- Device Name
- Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit EUDAMEDMalaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Ki EUDAMED
- Model / Reference
- SC20203W-50T EUDAMEDSC20203W-1T EUDAMEDSC20203W-20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SC20203W-50TWS EUDAMEDD-SC20203W-1T2B EUDAMEDD-SC20203W-20TWB EUDAMED
- Basic UDI-DI
- B-SC20203W-50TWS EUDAMEDB-SC20203W-1T2B EUDAMEDB-SC20203W-20TWB 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/Pv (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-SC20203W-50TWS | 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 (3)
- EUDAMED c7ebbd5f-9c42-4618-952d-ed365253be48 61 fields · synced Jul 12, 2026
- EUDAMED 7d567ea2-5655-4171-bcc9-9f934301b4ea 61 fields · synced May 17, 2026
- EUDAMED 6c73e54b-de86-4244-91e2-2b6b7c274c70 61 fields · synced May 18, 2026