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Hasa Optix

by Hasa Optix 98 variants

Ref 655041

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05404027427614 UDI-DI Date13 Nov 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-05404027427614 Basic UDI-DI Date30 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Hasa Optix EUDAMED
Sterile, Single Use, Speculum Adjustable Full Rounded Blades GUDID
Generic Name
Eyelid speculum, single-use
Device Name
655041x10: Sterile, Single Use, Speculum Adjustable Full Rounded Blades, L 65mm
655041: Sterile, Single Use, Speculum Adjustable Full Rounded Blades, L 65mm
Model / Reference
655041
Primary DI / UDI-DI
05404027427614, 05404027412788
Basic UDI-DI
B-05404027427614, B-05404027412788
FDA Product Code
HNC
EMDN Code
Q021106 Ophthalmic surgery dilators, single-use
GMDN Term
Eyelid speculum, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
BE-MF-000028219

Other devices from Hasa Optix

See all devices from Hasa Optix →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No