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W0103020606
EUDAMEDClass IVD General (EU MDR)
Ref T1604Model TriniCLOT Lupus Screen
Identity
- Trade Name
- W0103020606 EUDAMED
- Device Name
- TriniCLOT Lupus Screen EUDAMED
- Model / Reference
- TriniCLOT Lupus Screen EUDAMEDT1604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521420473 EUDAMED
- Basic UDI-DI
- B-05391521420473 EUDAMED
- EMDN Code
- W0103020606 LUPUS ANTICOAGULANT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
W0103020606 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-05391521420473 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED 4165d1a6-93e6-48bf-ba88-54df22c92831 61 fields · synced Jun 18, 2026