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Fibra Ottica Laser

by Garda Laser S.A.S. Di Cucinotta Salvatore

Ref FIBRA OTTICA LASER W00UM T METRI PF1WT00Model FIBRA OTTICA LASER

Active European Union

CE MDR

Valid until

2 Jul 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805296141PFUK Basic UDI-DI 08052961410055UDI-DIDate9 Dec 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FIBRA OTTICA LASER, FIBRA OTTICA LASER W00UM T METRI PF1WT00
Primary DI / UDI-DI
08052961410055
Basic UDI-DI
805296141PFUK
Direct Marketing DI
08052961410055
EMDN Code
Z12011085 Laser surgery instruments - consumables
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024386

Related devices

Category: Varicose vein lasing procedure kit

Other devices from Garda Laser S.A.S. Di Cucinotta Salvatore

  • Kit Tip Laser

    Class IIa

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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