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Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013796Model 2×50 Tests/kitRef 3010703Model 1×100 Tests/kitRef 3010683Model 1×50 Tests/kit
Identity
- Trade Name
- Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 Tests/kit EUDAMED3013796 EUDAMED1×100 Tests/kit EUDAMED3010703 EUDAMED1×50 Tests/kit EUDAMED3010683 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224287 EUDAMED06925794519177 EUDAMED06925794519160 EUDAMED
- Basic UDI-DI
- B-06942202224287 EUDAMEDB-06925794519177 EUDAMEDB-06925794519160 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 EUDAMEDW0102039007 NEURON SPECIFIC ENOLASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06942202224287 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 863dc900-68bf-405a-873f-7ec1ed1181e2 61 fields · synced Oct 6, 2026
- EUDAMED 429efced-2c94-4e17-9dbc-1c41c47d45ab 61 fields · synced May 18, 2026
- EUDAMED 4c98c504-62d7-41f0-89f4-934a008183e2 61 fields · synced May 19, 2026