Identity
- Trade Name
- MONALISA GLIDE - GLIDE EUDAMEDGlide EUDAMED
- Device Name
- MONALISA GLIDE EUDAMED
- Model / Reference
- M127B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108511450 EUDAMED
- Basic UDI-DI
- 803410851M127A1LZ EUDAMEDB-08034108511450 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
Monalisa Glide - Glide 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 | 803410851M127A1LZ | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803410851M127A1LZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 4da9b000-87ee-461d-ab5b-5b0e8445dc29 61 fields · synced Jul 13, 2026
- EUDAMED f2ba296b-1f81-465a-9615-ec273af931e3 61 fields · synced May 18, 2026