Identity
- Trade Name
- sthemA FL-50 EUDAMED
- Device Name
- sthemA FL-50 EUDAMED
- Model / Reference
- sthemA FL-50 EUDAMED01422 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521421791 EUDAMED
- Basic UDI-DI
- 53915214FL50JZ EUDAMED
- Direct Marketing DI
- 05391521421791 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
New Device
No
EUDAMED
sthemA FL-50 by Tcoag ireland ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 53915214FL50JZ | Class A | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (1)
- EUDAMED 5b3ac6ed-a4f9-4784-b8bb-c0d11be2df22 61 fields · synced Jun 19, 2026