Identity
- Trade Name
- KEYU Feces Formed Element Control EUDAMED
- Device Name
- Feces Formed Element Control EUDAMED
- Model / Reference
- QC-Ⅰ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360149 EUDAMED
- Basic UDI-DI
- B-06974735360149 EUDAMED
- EMDN Code
- W0101050199 MULTICOMPONENT CONTROLS (CC) - 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
No
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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 Feces Formed Element Control by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974735360149 | 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 eed3f1cf-813a-4501-8415-330192c8a62a 61 fields · synced Jun 19, 2026
- EUDAMED b147007d-0dbc-4bc6-a098-29885db01009 61 fields · synced Jun 19, 2026