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KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref FOB-A
Identity
- Trade Name
- KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method) EUDAMED
- Device Name
- Fecal Occult Blood Diagnostic Kit (colloidal gold method) EUDAMED
- Model / Reference
- FOB-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360798 EUDAMED
- Basic UDI-DI
- B-06974735360798 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 (colloidal gold method) 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-06974735360798 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c1be7579-1d3c-489f-8bb7-0f0750230787 61 fields · synced Jun 19, 2026