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Single Use Optical Fiber Performance

by Quanta System S.p.A. Italy EUDAMED

Ref OFC402011Model Single Use Optical Fiber EMDN Z12011080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805917339FT2011-01AU3 Basic UDI-DIDate1 Apr 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Single Use Optical Fiber
Model / Reference
Single Use Optical Fiber, OFC402011
Primary DI / UDI-DI
08059173393381
Basic UDI-DI
805917339FT2011-01AU3
Direct Marketing DI
08059173393381
EMDN Code
Z12011080 Laser surgery instruments - hardware accessories
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IT-MF-000007393

Other devices from Quanta System S.p.A.

See all devices from Quanta System S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 7f0aebb5-e5fc-4966-84d7-4dd6c143eb0a 61 fields · synced 25 Oct 2026