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Hasa Optix [EN]

by Hasa Optix

Ref HA-SET028Model HA-SET028 x10

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 Number05404027448459 UDI-DI Date22 Mar 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-05404027448459 Basic UDI-DI Date29 Sep 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  • Withdrawn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 [EN] EUDAMED
Rayner Cataract Set 28 GUDID
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Name
HA-SET028 x10:Sterile, Single Use,CATARACT SET RAYNER 28
HA-SET028: Sterile, Single Use,CATARACT SET RAYNER 28
Model / Reference
HA-SET028 x10, HA-SET028
Primary DI / UDI-DI
05404027448459, 05404027448442
Basic UDI-DI
B-05404027448459, B-05404027448442
FDA Product Code
PZG
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, 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
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No