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KEYU Calprotectin Test Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref FC-III
Identity
- Trade Name
- KEYU Calprotectin Test Kit (Colloidal gold method) EUDAMED
- Device Name
- Calprotectin Test Kit (Colloidal gold method) EUDAMED
- Model / Reference
- FC-III EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360606 EUDAMED
- Basic UDI-DI
- B-06974735360606 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 Test Kit (Colloidal gold method) 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-06974735360606 | 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 (1)
- EUDAMED bc2941c2-8fea-473b-b7f8-9bcca3d280ae 61 fields · synced Aug 3, 2026