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Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)
EUDAMEDClass IVD General (EU MDR)
Ref GEFOB/TF-602a
Identity
- Trade Name
- Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces) EUDAMED
- Device Name
- Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces) EUDAMED
- Model / Reference
- GEFOB/TF-602a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GEFOB/TF-602aHGZM EUDAMED
- Basic UDI-DI
- B-GEFOB/TF-602aHGZM EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces) by Healgen Scientific Limited Liability Company — Class IVD General — IVDD — listed in…
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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/TF-602aHGZM | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 43ab373c-3dba-48d3-8bbf-69b188a2abd1 61 fields · synced Oct 6, 2026