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Fibrinogen Degradation Product Kit（CLIA）
EUDAMEDClass IVD General (EU MDR)
Ref CA1409BModel 100T
Identity
- Trade Name
- Fibrinogen Degradation Product Kit（CLIA） EUDAMED
- Device Name
- Fibrinogen Degradation Product Kit（CLIA） EUDAMED
- Model / Reference
- 100T EUDAMEDCA1409B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978945081399 EUDAMED
- Basic UDI-DI
- B-06978945081399 EUDAMED
- EMDN Code
- W0103020502 FIBRINOGEN DEGRADATION PRODUCTS 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fibrinogen Degradation Product Kit（CLIA） by Jiangxi Medicalsystem Biological Technology 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-06978945081399 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050651
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED d0c0288c-e57e-4211-8b81-797209a408ab 61 fields · synced Jun 18, 2026