Identity
- Trade Name
- Smartxide2 C80H EUDAMED
- Device Name
- Smartxide2 C80H EUDAMEDSmartxide2 family EUDAMED
- Model / Reference
- M103H1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108511771 EUDAMED
- Basic UDI-DI
- B-08034108511771 EUDAMED803410851M103XXQG 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 C80H 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-08034108511771 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108511771 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 745884ea-3a60-4f64-8fa3-c3515de07fd7 61 fields · synced Jun 19, 2026
- EUDAMED 39badc26-fcce-400f-a04d-55af1830aec2 61 fields · synced May 17, 2026