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Ophthalmic Scissors Instruments DSP

by Alcon Laboratories, Inc. EUDAMEDGUDID

Active European Union

Ref 806.52

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000161H4 Basic UDI-DIDate8 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612717071643 UDI-DIDate27 Jun 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Finesse Reflex
Generic Name
Intraocular scissors, probe-like, single-use
Device Name
Ophthalmic Scissors Instruments DSP
Model / Reference
806.52
Primary DI / UDI-DI
07612717071643
Basic UDI-DI
038065GMN000161H4
FDA Product Code
HNF
EMDN Code
Q021103 Ophthalmic surgery scissors, single-use
GMDN Term
Intraocular scissors, probe-like, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 23 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Serial Number: No
  • Manufacturing Date: No