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Custom-Pak

by Alcon Laboratories, Inc. United States EUDAMED

Ref N/A

EMDN Q021113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000268HP Basic UDI-DIDate14 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
N/A
Primary DI / UDI-DI
05414660434269
Basic UDI-DI
038065GMN000268HP
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class I
Medical Purpose
The CUSTOM-PAK is intended to be used by ophthalmic surgeons in a variety of ophthalmic surgeries. The CUSTOM-PAK is configured according to the needs and preferences of individual medical teams for the specific procedures and disease states they diagnose and treat.

Manufacturer details

EUDAMED SRN
US-PR-000037951

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 0ea5fd9c-f4fb-4b5c-b932-b4355b449a4b 61 fields · synced 22 Oct 2026