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Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluoresce…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD159
Identity
- Trade Name
- Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Device Name
- Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Model / Reference
- GKPD159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD159XX EUDAMED
- Basic UDI-DI
- B-GKPD159XX 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 Pan-plasmodium Antigen Detection Kit (Immunofluoresce… 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-GKPD159XX | 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 4ea8bfa7-7bbb-4611-b05a-42375555586b 61 fields · synced Jun 18, 2026