Identity
- Trade Name
- M-T SYSTEM EUDAMED
- Device Name
- DISPOSITIVI per ANALISI DEL SEDIMENTO URINARIO - DEVICES for URINE SEDIMENT ANALYSIS EUDAMED
- Model / Reference
- BVS190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033673563536 EUDAMED
- Basic UDI-DI
- 803367356URINALYSISX2 EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
New Device
No
EUDAMED
M-T System by Biosigma S.p.a. — 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 | 803367356URINALYSISX2 | Class A | Active |
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Manufacturer
- Manufacturer
- Biosigma S.p.a.
- EUDAMED SRN
- IT-MF-000030370
Sources (1)
- EUDAMED b5db9c09-f646-43e4-abd4-a19ce9997111 61 fields · synced Jun 19, 2026