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Surgical Laser Fiber

by Quanta System S.p.A. EUDAMED510(k)GUDID

Active United States and European Union

Ref EMP-FBX272HSModel Single Use Optical Fiber

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805917339FT2011-01AU3 Basic UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033945938420 UDI-DIDate28 Sep 2018ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK160513 Date18 Mar 2016IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates: none listed in EUDAMED

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1844-2021 FDA Class II initiated 27 Apr 2021
    • Terminated Z-1843-2021 FDA Class II initiated 27 Apr 2021

    Product sterility is potentially compromised.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Surgical Laser Fiber EUDAMED
Single use Surgical Optical Fiber GUDID
Generic Name
Urogenital surgical laser system beam guide, single-use
Device Name
Single Use Optical Fiber
Model / Reference
Single Use Optical Fiber, EMP-FBX272HS
Primary DI / UDI-DI
08033945938420
Basic UDI-DI
805917339FT2011-01AU3
Direct Marketing DI
08033945938420
FDA Product Code
GEX
EMDN Code
Z12011080 Laser surgery instruments - hardware accessories
GMDN Term
Urogenital surgical laser system beam guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No