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KEYU Fecal Occult Blood Diagnostic Kit (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref FOB-F-IRef FOB-F-II
Identity
- Trade Name
- KEYU Fecal Occult Blood Diagnostic Kit (Fluorescence Immunochromatography) EUDAMED
- Device Name
- Fecal Occult Blood Diagnostic Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- FOB-F-I EUDAMEDFOB-F-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361153 EUDAMED06974735361160 EUDAMED
- Basic UDI-DI
- B-06974735361153 EUDAMEDB-06974735361160 EUDAMED
- EMDN Code
- W0101060399 FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
KEYU Fecal Occult Blood Diagnostic Kit (Fluorescence Immunochromatography) by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed…
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-06974735361153 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 8336dfff-81dd-479a-9f9e-16707da171d8 61 fields · synced Jul 8, 2026
- EUDAMED 08bde04e-c921-4796-bad9-10fd1ce36ad3 61 fields · synced May 18, 2026