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Cystatin C Assay Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DL246002Model 50tests/kitRef 20 tests/ kitRef DL246001CModel 20 tests/kit
Identity
- Trade Name
- Cystatin C Assay Kit (Fluorescence Immunoassay) EUDAMEDCystatin C Assay Kit（Fluorescence Immunoassay） EUDAMED
- Device Name
- Cystatin-C Assay Kit（Fluorescence Immunoassay） EUDAMEDCystatin C Assay Kit（Fluorescence Immunoassay） EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDDL246002 EUDAMED20 tests/ kit EUDAMED20 tests/kit EUDAMEDDL246001C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424225015 EUDAMED06975424223264 EUDAMED06975424225756 EUDAMED
- Basic UDI-DI
- B-06975424225015 EUDAMEDB-06975424223264 EUDAMEDB-06975424225756 EUDAMED
- EMDN Code
- W0102019008 CYSTATIN C 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
Cystatin C 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-06975424225015 | 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 (3)
- EUDAMED 71bf3a60-299d-46be-aa6d-60bf4596a0e8 61 fields · synced Oct 7, 2026
- EUDAMED 0a003cae-f5f3-4efe-8b80-d3fcc95f431e 61 fields · synced May 18, 2026
- EUDAMED 3a812b37-5022-428c-8dad-35bc790b9ca2 61 fields · synced Jul 8, 2026