← Back to catalogue
KEYU Fecal Calprotectin Test Kit (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref FC-F-IRef FC-F-Ⅱ
Identity
- Trade Name
- KEYU Fecal Calprotectin Test Kit (Fluorescence Immunochromatography) EUDAMED
- Device Name
- Fecal Calprotectin Test Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- FC-F-I EUDAMEDFC-F-Ⅱ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361092 EUDAMED06974735361108 EUDAMED
- Basic UDI-DI
- B-06974735361092 EUDAMEDB-06974735361108 EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN 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 Calprotectin Test Kit (Fluorescence Immunochromatography) by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed in…
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-06974735361092 | 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
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED cd08ed85-2a12-403e-83fa-ac1f28ee20c7 61 fields · synced Oct 6, 2026
- EUDAMED cb0e541c-3772-4cb7-bfc3-35a38a5d1f39 61 fields · synced May 18, 2026