Identity
- Trade Name
- SmartXide EUDAMED
- Device Name
- SMARTXIDE family EUDAMEDSMARTXIDE EUDAMED
- Model / Reference
- M079S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510484 EUDAMED
- Basic UDI-DI
- 803410851M079XXSL EUDAMEDB-08034108510484 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 by Deka M.e.l.a. Srl — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 803410851M079XXSL | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803410851M079XXSL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED d4559038-86e2-4802-8c44-8b3afe5e0686 61 fields · synced Jul 17, 2026
- EUDAMED eeec16f6-5fd1-429e-b0c7-0777b24d17b8 61 fields · synced May 19, 2026