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KEYU Feces Sediment Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref FFE-QC-ARef FFE-QC-DRef FFE-QC-C
Identity
- Trade Name
- KEYU Feces Sediment Quality Control EUDAMED
- Device Name
- Feces Sediment Quality Control EUDAMED
- Model / Reference
- FFE-QC-A EUDAMEDFFE-QC-D EUDAMEDFFE-QC-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361221 EUDAMED06974735361252 EUDAMED06974735361245 EUDAMED
- Basic UDI-DI
- B-06974735361221 EUDAMEDB-06974735361252 EUDAMEDB-06974735361245 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
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 Feces Sediment Quality 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-06974735361221 | 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 (3)
- EUDAMED 8fd9df6d-d342-43d0-b918-66b05d0fc137 61 fields · synced Jul 30, 2026
- EUDAMED ea6eb27a-d215-46ae-8c48-db3d22351dac 61 fields · synced May 17, 2026
- EUDAMED 8a61b7dc-f7b0-42a4-8702-0987b2f116d0 61 fields · synced May 18, 2026