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Ophthalmic Knives

by Alcon Laboratories, Inc. United States EUDAMEDGUDID

Ref 681.01

Product code HNNEMDN Q02010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000159HH Basic UDI-DIDate8 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612717000032 UDI-DIDate19 Aug 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Alcon Grieshaber
Generic Name
Ophthalmic knife, reusable
Device Name
Ophthalmic Knives
Model / Reference
681.01
Primary DI / UDI-DI
07612717000032
Basic UDI-DI
038065GMN000159HH
Direct Marketing DI
07612717000032
FDA Product Code
HNN
EMDN Code
Q02010101 Ophthalmic microknives, straight
GMDN Term
Ophthalmic knife, reusable
Device Class
Class I
Regulation Number
886.4350
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
Yes
GUDID
No

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 & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDNoGUDID
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No

Sources (2)

  • EUDAMED d0026f1c-5711-4b90-885c-baf1565083a7 61 fields · synced 22 Oct 2026
  • FDA UDI c6aa84de-bbfc-4aa2-a6fa-e08ef044e442 34 fields · synced 30 May 2026