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by FOTONA, proizvodnja optoelektronskih naprav d.o.o. 9 variants

Ref S11

Scanner (S11) 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 6 Nov 2026 (Basic UDI-DI 3830054230013S8), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3830054230013S8 Basic UDI-DI 03830054234932UDI-DIDate6 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
S11
Primary DI / UDI-DI
03830054234932
Basic UDI-DI
3830054230013S8
Direct marketing DI
03830054234123
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
SI-MF-000000126

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
Other properties (13, all answered No)