Identity
- Trade Name
- Smartxide2 C60 EUDAMED
- Device Name
- Smartxide2 family EUDAMEDSmartxide2 C60 EUDAMED
- Model / Reference
- M103F1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510446 EUDAMED
- Basic UDI-DI
- 803410851M103XXQG EUDAMEDB-08034108510446 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 C60 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 b48c0ab0-543f-4585-a0d1-c4061d4cb6b6 61 fields · synced Jul 15, 2026
- EUDAMED faf1a47e-a8e3-4c3c-9160-b56dad353f6d 61 fields · synced May 19, 2026