Identity
- Trade Name
- SMART US-20 D EUDAMED
- Device Name
- SMART US-20 D EUDAMEDSMARTXIDE family EUDAMED
- Model / Reference
- M079A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510088 EUDAMED
- Basic UDI-DI
- B-08034108510088 EUDAMED803410851M079XXSL EUDAMED
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Smart Us-20 D by Deka M.e.l.a. Srl — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08034108510088 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108510088 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 0b8434af-93db-4658-ac69-2ea63125e6c3 61 fields · synced Jul 30, 2026
- EUDAMED c128aa9d-b55c-42c5-995e-43e30a085c4b 61 fields · synced May 19, 2026