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KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref FOB-CRef FOB-B
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-C EUDAMEDFOB-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360651 EUDAMED06974735360378 EUDAMED
- Basic UDI-DI
- B-06974735360651 EUDAMEDB-06974735360378 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-06974735360651 | 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 (2)
- EUDAMED ec8aeb94-9835-423a-b021-b4a0a23c8fc7 61 fields · synced Jul 27, 2026
- EUDAMED 8dc69c19-98d1-405f-98cf-454880d56118 61 fields · synced May 19, 2026