← Back to catalogue
KEYU Feces Formed Element Control
EUDAMEDClass IVD General (EU MDR)
Ref QC-ⅡRef QC-Ⅴ
Identity
- Trade Name
- KEYU Feces Formed Element Control EUDAMED
- Device Name
- Feces Formed Element Control EUDAMED
- Model / Reference
- QC-Ⅱ EUDAMEDQC-Ⅴ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360446 EUDAMED06974735360477 EUDAMED06974735362105 EUDAMED
- Basic UDI-DI
- B-06974735360446 EUDAMEDB-06974735360477 EUDAMEDB-06974735362105 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-06974735360446 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 82e5d554-74ab-41b4-99aa-f5f1411e9423 61 fields · synced Oct 5, 2026
- EUDAMED b1a3b85a-cd41-469b-a987-d348615e951e 61 fields · synced May 18, 2026
- EUDAMED 5df20afb-e63d-498b-837e-6bfd2bb9ee28 61 fields · synced Jul 10, 2026
- EUDAMED 95380123-d099-400c-b80b-1268d7c31183 61 fields · synced Jul 15, 2026
- EUDAMED b2f6781b-88d0-4012-a002-167c44a25a04 61 fields · synced Oct 5, 2026