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SOFTEC Fecal Occult Blood Test (FOB Test)
EUDAMEDClass IVD General (EU MDR)
Ref SGGT-101
Identity
- Trade Name
- SOFTEC Fecal Occult Blood Test (FOB Test) EUDAMED
- Device Name
- SOFTEC Fecal Occult Blood Test (FOB Test) EUDAMED
- Model / Reference
- SGGT-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616046 EUDAMED
- Basic UDI-DI
- B-08697962616046 EUDAMED
- EMDN Code
- W0102039013 FECAL OCCULT BLOOD (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SOFTEC Fecal Occult Blood Test (FOB Test) by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — 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-08697962616046 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED 8b77d4a4-60ee-48c4-8d71-dc611d479603 61 fields · synced Oct 6, 2026