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D-Dimer Assay Kit（Fluorescence Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref 20 tests/ kitRef DL202306Model 50tests/kit
Identity
- Trade Name
- D-Dimer Assay Kit（Fluorescence Immunoassay） EUDAMED
- Device Name
- D-Dimer Assay Kit（Fluorescence Immunoassay） EUDAMED
- Model / Reference
- 20 tests/ kit EUDAMED50tests/kit EUDAMEDDL202306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424221420 EUDAMED06975424223738 EUDAMED
- Basic UDI-DI
- B-06975424221420 EUDAMEDB-06975424223738 EUDAMED
- EMDN Code
- W01021399 CARDIAC MARKERS - OTHER 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
D-Dimer 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-06975424221420 | 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 a98a95c4-7d81-4c56-acf6-02ed3d754afb 61 fields · synced Oct 7, 2026
- EUDAMED 0a60123d-9ce3-43b2-89c7-b9b638ced8dd 61 fields · synced May 18, 2026