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KEYU Fecal Occult Blood Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref FOB-R-GRef FOB-R-F
Identity
- Trade Name
- KEYU Fecal Occult Blood Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- Fecal Occult Blood Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- FOB-R-G EUDAMEDFOB-R-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360859 EUDAMED06974735360866 EUDAMED
- Basic UDI-DI
- B-06974735360859 EUDAMEDB-06974735360866 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 Rapid Test (Colloidal Gold) by Zhuhai Keyu Biological Engineering 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-06974735360859 | 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 f8bd004f-16cf-41d3-964b-1195b084f1bc 61 fields · synced Jul 9, 2026
- EUDAMED 9ea520ad-aba5-4c7d-a213-6d0a229b439e 61 fields · synced May 18, 2026