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ModifEYE™

by Alcon Laboratories, Inc. 4 variants

Ref 337.64

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000153H5 Basic UDI-DI 07612717072060UDI-DIDate8 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612717072060 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
ModifEYE™ EUDAMED
FINESSE ModifEYE GUDID
Generic Name
Vitrectomy fluid/gas handling handpiece/cannula
Device Name
Vitrectomy fluid/gas handling instruments DSP
Model / Ref / Catalog
337.64
Primary DI / UDI-DI
07612717072060
Basic UDI-DI
038065GMN000153H5
FDA Product Code
HMX
EMDN Code
Z12120285 Therapeutic and surgical ophtholmological treatments instruments - consumables
GMDN Term
Vitrectomy fluid/gas handling handpiece/cannula
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 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
  • Manufacturing Date

Other properties (16)

  • 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