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TriniCHECK Level 2
EUDAMEDClass IVD General (EU MDR)
Ref T4112Model TriniCHECK Level 2
Identity
- Trade Name
- TriniCHECK Level 2 EUDAMED
- Device Name
- TriniCHECK Level 2 EUDAMED
- Model / Reference
- TriniCHECK Level 2 EUDAMEDT4112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521420640 EUDAMED
- Basic UDI-DI
- B-05391521420640 EUDAMED
- EMDN Code
- W0103020702 CONTROL PLASMA FOR HAEMOSTASIS 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
TriniCHECK Level 2 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-05391521420640 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED 37d15bd3-f372-43e1-93fa-4073e683e0a9 61 fields · synced Jun 18, 2026