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TriniCLOT Factor XI
EUDAMEDClass IVD General (EU MDR)
Ref T1511Model TriniCLOT Factor XI
Identity
- Trade Name
- TriniCLOT Factor XI EUDAMED
- Device Name
- TriniCLOT Factor XI EUDAMED
- Model / Reference
- TriniCLOT Factor XI EUDAMEDT1511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521420435 EUDAMED
- Basic UDI-DI
- B-05391521420435 EUDAMED
- EMDN Code
- W0103020210 COAGULATION FACTOR XI EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
TriniCLOT Factor XI 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-05391521420435 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED b9993f42-0b34-4534-bf22-8d1c1609cf30 61 fields · synced Jun 19, 2026