Identity
- Trade Name
- Smartxide2 C40 EUDAMED
- Device Name
- Smartxide2 family EUDAMEDSmartxide2 C40 EUDAMED
- Model / Reference
- M103G1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510439 EUDAMED
- Basic UDI-DI
- 803410851M103XXQG EUDAMEDB-08034108510439 EUDAMED
- EMDN Code
- Z12011019 MULTI–PLATFORM 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
Smartxide2 C40 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 | 803410851M103XXQG | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803410851M103XXQG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 6fcff063-039a-420c-9e49-19711b27ed57 61 fields · synced Jul 11, 2026
- EUDAMED 7d9b632e-cb39-4cbc-9c3f-81db81f0225e 61 fields · synced May 19, 2026