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Cytokeratin 19 Fragment 21-1 Determination Kit (Fluorescence Immunochromatograp…
EUDAMEDClass C (EU MDR)
Ref P12208Model 25 tests/box
Identity
- Trade Name
- Cytokeratin 19 Fragment 21-1 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Cytokeratin 19 Fragment 21-1 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP12208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581016 EUDAMED
- Basic UDI-DI
- 697518250P122086B EUDAMED
- Direct Marketing DI
- 06942293581016 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
Cytokeratin 19 Fragment 21-1 Determination Kit (Fluorescence Immunochromatograp… by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P122086B | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 12b489b5-5859-4c20-b171-a2424c5dc69a 61 fields · synced Oct 6, 2026