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05993022298386

by Medicontur Medical Engineering Ltd.

Ref 05993022298386Model 677CTA

Active European Union

CE MDR

Valid until

10 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number599302677CTARP Basic UDI-DI 05993022298386UDI-DIDate2 Jun 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-MDR/QS-048/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    12 Dec 2024
    Expires
    10 Nov 2028
    Reason
    Other
  • 2023-MDR/TD-048/A Active Supplemented

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    12 Dec 2024
    Expires
    10 Nov 2028
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
677CTA, 05993022298386
Primary DI / UDI-DI
05993022298386
Basic UDI-DI
599302677CTARP
EMDN Code
P030102090302 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000024195

Other devices from Medicontur Medical Engineering Ltd.

See all devices from Medicontur Medical Engineering Ltd. →

Properties

  • 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