Identity
- Trade Name
- Duo Glide EUDAMEDMONALISA GLIDE - DUOGLIDE EUDAMED
- Device Name
- MONALISA GLIDE EUDAMED
- Model / Reference
- M127A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108511443 EUDAMED
- Basic UDI-DI
- B-08034108511443 EUDAMED803410851M127A1LZ 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
Duo Glide 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-08034108511443 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08034108511443 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (2)
- EUDAMED 2bf4e943-de9c-40b9-972c-3a58f7ec85e5 61 fields · synced Aug 2, 2026
- EUDAMED 4214d36a-a1c3-482d-9d78-29f4b00042c9 61 fields · synced May 18, 2026