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Malaria Pan Ag Rapid Test Cassette (Whole Blood)
EUDAMEDClass IVD General (EU MDR)
Ref GCMAL(pan)-402a
Identity
- Trade Name
- Malaria Pan Ag Rapid Test Cassette (Whole Blood) EUDAMED
- Device Name
- Malaria Pan Ag Rapid Test Cassette (Whole Blood) EUDAMED
- Model / Reference
- GCMAL(pan)-402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCMAL(pan)-402aAX EUDAMED
- Basic UDI-DI
- B-GCMAL(pan)-402aAX 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
Malaria Pan Ag Rapid Test Cassette (Whole Blood) by Zhejiang Orient Gene Biotech 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-GCMAL(pan)-402aAX | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 54b589d4-dad8-4c7b-8cbd-25a7730837d5 61 fields · synced Jun 18, 2026