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FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces)
EUDAMEDClass IVD General (EU MDR)
Ref GEFTHRA-T636a
Identity
- Trade Name
- FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces) EUDAMED
- Device Name
- FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces) EUDAMED
- Model / Reference
- GEFTHRA-T636a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GEFTHRA-T636a7B EUDAMEDD-GEFTHRA-T636aHG6E EUDAMED
- Basic UDI-DI
- B-GEFTHRA-T636a7B EUDAMEDB-GEFTHRA-T636aHG6E EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMEDW0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces) 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-GEFTHRA-T636a7B | 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 (2)
- EUDAMED e8c932a8-a9a9-48d3-8ed8-8d6385e1a9cf 61 fields · synced Oct 6, 2026
- EUDAMED 4cbfef16-933a-4742-ac08-305a61041e25 61 fields · synced May 17, 2026