Skip to content

Hasa Optix

by Hasa Optix Belgium EUDAMED

Ref 555004

EMDN Q021106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05404027412382 Basic UDI-DIDate3 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
555004: Sterile, Single Use, Wire Speculum, 7mm And 9mm Open Blades, L 47mm
555004x10: Sterile, Single Use, Wire Speculum, 7mm And 9mm Open Blades, L 47mm
Model / Reference
555004
Primary DI / UDI-DI
05404027412382, 05404027427218
Basic UDI-DI
B-05404027412382, B-05404027427218
EMDN Code
Q021106 Ophthalmic surgery dilators, single-use
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000028219

Other devices from Hasa Optix

See all devices from Hasa Optix →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED ab6583ab-7c52-4ae1-9412-f05a68b789ad 61 fields · synced 22 Oct 2026
  • EUDAMED d514389b-3f3f-407c-a823-805b6971573a 61 fields · synced 16 May 2026