Handpiece
by FOTONA, proizvodnja optoelektronskih naprav d.o.o. 57 variants
Part of a family of 57 devices: see the family page
Ref Leo
Handpiece (Leo) is a medical device (EU MDR Class IIb; EMDN category laser surgery instruments - hardware accessories) made by FOTONA, proizvodnja optoelektronskih naprav d.o.o., registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 3830054230002S3), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3830054230002S3 03830054237674 | Date20 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 3830054230002S3
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- Leo
- Primary DI / UDI-DI
- 03830054237674
- Basic UDI-DI
- 3830054230002S3
- Direct marketing DI
- 03830054237674
- EMDN code
- Z12011080 Laser surgery instruments - hardware accessories
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000000126
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