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Fragments of Cytokeratin 19 Kit(CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref FG1210YModel 100T
Identity
- Trade Name
- Fragments of Cytokeratin 19 Kit(CLIA) EUDAMED
- Device Name
- Fragments of Cytokeratin 19 Kit(CLIA) EUDAMED
- Model / Reference
- 100T EUDAMEDFG1210Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595751321 EUDAMED
- Basic UDI-DI
- B-06936595751321 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fragments of Cytokeratin 19 Kit(CLIA) by Medicalsystem Biotechnology 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-06936595751321 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1017458b-918f-4e80-8d74-32446a600fd7 61 fields · synced Oct 6, 2026