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TriniCAL Fibrinogen
EUDAMEDClass IVD General (EU MDR)
Ref T5104Model TriniCAL Fibrinogen
Identity
- Trade Name
- TriniCAL Fibrinogen EUDAMED
- Device Name
- TriniCAL Fibrinogen EUDAMED
- Model / Reference
- TriniCAL Fibrinogen EUDAMEDT5104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521420725 EUDAMED
- Basic UDI-DI
- B-05391521420725 EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
TriniCAL Fibrinogen by Tcoag ireland 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-05391521420725 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED bee6d1ca-56b9-4c98-ab99-5e860fb9090b 61 fields · synced Jul 13, 2026