Identity
- Trade Name
- HiScan Surgical EUDAMED
- Device Name
- Scanning units for CO2 lasers EUDAMED
- Model / Reference
- F270C1 EUDAMEDF163A1 EUDAMEDF16301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108513553 EUDAMED08034108512013 EUDAMED08034108512006 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 Surgical 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 a230a157-3f5c-499c-844c-929fd2f39fad 61 fields · synced Aug 2, 2026
- EUDAMED cba13c02-9c5b-4c3e-8673-ef5a104b5d2e 61 fields · synced May 17, 2026
- EUDAMED 13a83309-c3ee-4946-939e-c6f2d73460fc 61 fields · synced May 18, 2026