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Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoas…
EUDAMEDClass IVD General (EU MDR)
Ref DL191206Model 50tests/kitRef 20 tests/ kitRef DL191201CModel 20 tests/kit
Identity
- Trade Name
- Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay) EUDAMED
- Device Name
- Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDDL191206 EUDAMED20 tests/ kit EUDAMED20 tests/kit EUDAMEDDL191201C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424223684 EUDAMED06975424221291 EUDAMED06975424225435 EUDAMED
- Basic UDI-DI
- B-06975424223684 EUDAMEDB-06975424221291 EUDAMEDB-06975424225435 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
Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoas… by DiYaLab ZJG Biotech 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-06975424223684 | 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 db245d4e-ac47-44b4-97cc-9b42f0718ce9 61 fields · synced Oct 7, 2026
- EUDAMED 9a5a38cf-774f-4f97-bfce-702465971322 61 fields · synced May 18, 2026
- EUDAMED 70d7b6fb-f96c-420d-9633-c352e0cc7592 61 fields · synced Jul 8, 2026