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Fecal Occult Blood & Transferrin Test (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HB+TF1FEST-XModel Cassette
Identity
- Trade Name
- Fecal Occult Blood & Transferrin Test (Colloidal Gold) EUDAMED
- Device Name
- Fecal Occult Blood & Transferrin Test (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette EUDAMEDHB+TF1FEST-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062772668 EUDAMED
- Basic UDI-DI
- B-06952062772668 EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fecal Occult Blood & Transferrin Test (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD devices for self-testing — IVDD — listed in…
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-06952062772668 | Class IVD devices for self-testing | 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 aabe3d54-bc3a-4464-99b3-91d78ec02546 61 fields · synced Oct 9, 2026