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Malaria pf/pv Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref Mal pf/pv-W11M Mal pf/pv-W23MModel Mal pf/pv-W11M, Mal pf/pv-W23M
Identity
- Trade Name
- Malaria pf/pv Rapid Test EUDAMED
- Device Name
- Malaria pf/pv Rapid Test EUDAMED
- Model / Reference
- Mal pf/pv-W11M, Mal pf/pv-W23M EUDAMEDMal pf/pv-W11M Mal pf/pv-W23M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804816544 EUDAMED
- Basic UDI-DI
- B-06952804816544 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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 pf/pv Rapid Test by Assure Tech. (hangzhou) 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-06952804816544 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4b13fc14-a641-4246-a45b-46ffe983744d 61 fields · synced Jun 18, 2026