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Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluores…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD160
Identity
- Trade Name
- Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Device Name
- Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Model / Reference
- GKPD160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD160XG EUDAMED
- Basic UDI-DI
- B-GKPD160XG 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
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
Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluores… by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-GKPD160XG | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 6bfc99c7-1b5b-4188-9492-c905461c9cab 61 fields · synced Jul 9, 2026