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Malaria P.f./Pan Antigen Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref K290916D
Identity
- Trade Name
- Malaria P.f./Pan Antigen Rapid Test Device EUDAMED
- Device Name
- Malaria P.f./Pan Antigen Rapid Test Device EUDAMED
- Model / Reference
- K290916D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050464 EUDAMED
- Basic UDI-DI
- B-06971792050464 EUDAMED
- EMDN Code
- W0105050209 PLASMODIUM (MALARIA) 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 Antigen Rapid Test Device by Hangzhou Realy Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971792050464 | Class IVD General | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 7ab3dd4e-7e91-43b9-a089-63cc966eae06 61 fields · synced Jun 18, 2026