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Fractional CO2 Laser Therapy System

by Beijing ADSS Development Co., Ltd EUDAMED

Active European Union

Ref Fractional CO2 Laser Therapy SystemModel FG900，FG900-S，FG900-S2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697045327FG900AP Basic UDI-DIDate29 Jun 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  • Withdrawn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

Model / Reference
FG900，FG900-S，FG900-S2, Fractional CO2 Laser Therapy System
Primary DI / UDI-DI
06970453271194
Basic UDI-DI
697045327FG900AP
Direct Marketing DI
06970453271194
EMDN Code
Z12011005 Carbon dioxide surgical laser
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013103
Authorised representative
Prolinx GmbH DE-AR-000005129

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Properties

Show 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