Identity
- Trade Name
- DT 100 EUDAMED
- Device Name
- DT 100 EUDAMED
- Model / Reference
- H02000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521421234 EUDAMED
- Basic UDI-DI
- B-05391521421234 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Dt 100 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-05391521421234 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED 4ea16315-eedd-4a07-a533-cfe540373f10 61 fields · synced Jul 9, 2026