Skip to content

Hasa Optix

by Hasa Optix 1,000+ variants

Ref 554054

Active European Union

CE MDD

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 24 Oct 2026. What this means

Overview

The HASA OPTIX device is a sterile, single-use phaco chopper designed for use in ophthalmic surgery. It features a Class IIa sterility indicator, a left-hand orientation, and a 110mm diameter. The device has been certified by the FDA as a medical device and is available for purchase through authorized distributors.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05404027422473 Basic UDI-DI Date28 Jan 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
554054x10: Sterile, Single Use, Phaco Chopper, Left Hand, 110mm
554054: Sterile, Single Use, Phaco Chopper, Left Hand, 110mm
Model / Reference
554054
Primary DI / UDI-DI
05404027422473, 05404027407647
Basic UDI-DI
B-05404027422473, B-05404027407647
EMDN Code
Q021199 Ophthalmic surgery instruments, single-use - other
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000028219

Other devices from Hasa Optix

See all devices from Hasa Optix →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No