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Fecal Occult Blood/Transferrin Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/KitRef 40 Tests/Kit
Identity
- Device Name
- Fecal Occult Blood/Transferrin Combo Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED40 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204439 EUDAMED06975166204477 EUDAMED
- Basic UDI-DI
- B-06975166204439 EUDAMEDB-06975166204477 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER 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
Yes
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/Transferrin Combo Rapid Test by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975166204439 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 7f99d7fb-ba45-4239-9fee-88c65022b787 61 fields · synced Jul 29, 2026
- EUDAMED 2d0f6f6f-4de0-4e0b-a84b-d7e1189351ee 61 fields · synced Jul 18, 2026
- EUDAMED 7074301d-4f73-4d76-889d-89bc9fff842b 61 fields · synced Jul 29, 2026