← Back to catalogue
KEYU Calprotectin Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref FC-R-FRef FC-R-G
Identity
- Trade Name
- KEYU Calprotectin Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- Calprotectin Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- FC-R-F EUDAMEDFC-R-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360903 EUDAMED06974735360897 EUDAMED
- Basic UDI-DI
- B-06974735360903 EUDAMEDB-06974735360897 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 Calprotectin Rapid Test (Colloidal Gold) 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-06974735360903 | 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 da644cef-1a26-4f57-a1d3-fa07d2b50827 61 fields · synced Oct 6, 2026
- EUDAMED 2b8c4235-c7ae-47fc-82bb-221dac6d29b5 61 fields · synced May 18, 2026