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Fecal Occult Blood Rapid Test Cassette (Feces)
EUDAMEDClass IVD General (EU MDR)
Ref GEFOB-602Cb
Identity
- Trade Name
- Fecal Occult Blood Rapid Test Cassette (Feces) EUDAMED
- Device Name
- Fecal Occult Blood Rapid Test Cassette (Feces) EUDAMED
- Model / Reference
- GEFOB-602Cb EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GEFOB-602CbSD EUDAMED
- Basic UDI-DI
- B-GEFOB-602CbSD EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Fecal Occult Blood Rapid Test Cassette (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-GEFOB-602CbSD | 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 4b950090-40be-4d53-b4e9-306b7c82334a 61 fields · synced Jun 19, 2026