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Leonardo®, Set

by CeramOptec GmbH EUDAMED

Active European Union

Ref SL1064nm60W

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number404905949NU Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Leonardo®, Set
Model / Reference
SL1064nm60W
Primary DI / UDI-DI
04049059301191
Basic UDI-DI
404905949NU
EMDN Code
Z12011016 Diode surgical laser
Device Class
Class IIb
Medical Purpose
Leonardo® is a medical laser for tissue treatment that delivers laser light through medical optical fibers for incision, excision, vaporization, ablation, hemostasis or coagulation at the application site during surgical procedures.

Manufacturer details

EUDAMED SRN
DE-PR-000052739

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Properties

Other properties (1)

  • Sterile: No