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Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref HGCL25Model Please see the IFU
Identity
- Trade Name
- Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700404777 EUDAMED
- Basic UDI-DI
- 697029753464LY EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
New Device
No
EUDAMED
Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697029753464LY | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cc50e851-870c-4213-bc00-4df781226b66 61 fields · synced Oct 6, 2026