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Fecal Occult Blood (FOB) Test (Colloidal Gold), Cassette
EUDAMEDClass IVD General (EU MDR)
Ref FOB1FE-1Model Cassette Strip Tube
Identity
- Trade Name
- Fecal Occult Blood (FOB) Test (Colloidal Gold), Cassette EUDAMED
- Device Name
- Fecal Occult Blood (FOB) Test (Colloidal Gold), Cassette EUDAMED
- Model / Reference
- Cassette Strip Tube EUDAMEDFOB1FE-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062770749 EUDAMED
- Basic UDI-DI
- B-06952062770749 EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC 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
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 (FOB) Test (Colloidal Gold), Cassette by Anhui Deepblue Medical Technology 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-06952062770749 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 0a41e6dd-9822-4f75-ab36-ee9158a85e34 61 fields · synced Oct 7, 2026