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Calprotectin Assay Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 20TRef DL245603Model 50tests/kit
Identity
- Trade Name
- Calprotectin Assay Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- Calprotectin Assay Kit (Fluorescence Immunoassay) EUDAMEDCalprotectin Assay Kit(Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 20T EUDAMED50tests/kit EUDAMEDDL245603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424223127 EUDAMED06975424225008 EUDAMED
- Basic UDI-DI
- B-06975424223127 EUDAMEDB-06975424225008 EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Calprotectin Assay Kit (Fluorescence Immunoassay) by DiYaLab ZJG Biotech 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-06975424223127 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DiYaLab ZJG Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000048648
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 71332bef-facd-4f2f-8ff0-ca5725288f34 61 fields · synced Jul 11, 2026
- EUDAMED 68c5be8a-6081-4135-a4a8-cef7147b7f5f 61 fields · synced May 19, 2026