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Custom-Pak

by Alcon Laboratories, Inc. 4 variants

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038065GMN000258HL Basic UDI-DI 05414660434221UDI-DIDate14 Nov 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Primary DI / UDI-DI
05414660434221
Basic UDI-DI
038065GMN000258HL
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class IIb
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.

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Properties

  • Sterile