Identity
- Trade Name
- SMARTXIDE TOUCH C60 EUDAMED
- Device Name
- SMARTXIDE TOUCH C60 EUDAMEDSMARTXIDE TOUCH EUDAMED
- Model / Reference
- M110B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510361 EUDAMED
- Basic UDI-DI
- B-08034108510361 EUDAMED803410851M110XXQ8 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
Smartxide Touch C60 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-08034108510361 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108510361 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED c96e9849-124c-4e5a-b1a9-7b9f0240e0e1 61 fields · synced Jul 23, 2026
- EUDAMED fb01c157-4b1a-46ee-a266-7d6da89a205b 61 fields · synced May 19, 2026