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05993023022133

by Medicontur Medical Engineering Ltd. Hungary EUDAMED

Ref 05993023022133Model A45SML

EMDN P030102100202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number599302A45SMLWT Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-MDR/QS-070 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    12 Dec 2024
    Expires
    10 Nov 2028
  • 2024-MDR/TD-070 Issued

    Technical documentation EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    12 Dec 2024
    Expires
    10 Nov 2028

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
A45SML, 05993023022133
Primary DI / UDI-DI
05993023022133
Basic UDI-DI
599302A45SMLWT
EMDN Code
P030102100202 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000024195

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6567ecc0-8c54-4159-b002-c42f04d2f5fb 61 fields · synced 23 Oct 2026