Identity
- Trade Name
- SmartXide Punto 30 EUDAMED
- Device Name
- Smartxide Punto 30 EUDAMEDSmartxide Punto / Tetra Pro EUDAMED
- Model / Reference
- M118A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510835 EUDAMED
- Basic UDI-DI
- B-08034108510835 EUDAMED803410851M118XXRG 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 Punto 30 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-08034108510835 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108510835 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED e14f60e4-8a2f-474a-b2b1-ad89bce8783d 61 fields · synced Jul 10, 2026
- EUDAMED aa7de4e4-cb55-455e-a220-0a5752a0d986 61 fields · synced May 17, 2026