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Non-ablative Fractional Laser Systems

by Wingderm Electro-Optics Ltd. EUDAMED

Active European Union

Ref WFC-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697297806005F100001CX Basic UDI-DIDate20 Oct 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
WFC-01
Primary DI / UDI-DI
06972978060055
Basic UDI-DI
697297806005F100001CX
Direct Marketing DI
06972978060055
EMDN Code
X0501 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – laser
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007136
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties

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