Identity
- Trade Name
- HiScan DOT EUDAMEDHiScan DOT S EUDAMEDHiScan DOT + EUDAMED
- Device Name
- Scanning units for CO2 lasers EUDAMED
- Model / Reference
- E124U1 EUDAMEDF397C1 EUDAMEDF269A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108512822 EUDAMED08034108513096 EUDAMED08034108512020 EUDAMED
- Basic UDI-DI
- 803410851F49801KD EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER 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
HiScan DOT by Deka M.e.l.a. Srl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803410851F49801KD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (3)
- EUDAMED 4664e85b-ad82-4d02-9039-b0bc74b6eec8 61 fields · synced Sep 17, 2026
- EUDAMED af9159d2-7ff4-4ccb-a4d7-e66d8c5ae88b 61 fields · synced May 18, 2026
- EUDAMED c6d49986-21f8-4068-b4ba-e483f03d37db 61 fields · synced May 19, 2026