Identity
- Trade Name
- SMARTXIDE HS EUDAMED
- Device Name
- SMARTXIDE HS EUDAMEDSMARTXIDE family EUDAMED
- Model / Reference
- M079Q2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510040 EUDAMED
- Basic UDI-DI
- B-08034108510040 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
Smartxide Hs 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-08034108510040 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108510040 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 14190e4a-2561-4b1c-ba26-dcbeee76236b 61 fields · synced Jun 19, 2026
- EUDAMED 62cc116f-84d2-413e-b764-652b3aa97523 61 fields · synced May 18, 2026