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SkyWave

by FOTONA, proizvodnja optoelektronskih naprav d.o.o. Slovenia EUDAMED

Ref M321-B

EMDN Z12011019

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3830054230014SA Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
M321-B
Primary DI / UDI-DI
03830054237759
Basic UDI-DI
3830054230014SA
EMDN Code
Z12011019 Multi–platform laser
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SI-MF-000000126

Other devices from FOTONA, proizvodnja optoelektronskih naprav d.o.o.

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 03830054237759|3830054230014SA 61 fields · synced 25 Oct 2026