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MINT Surgical Device

by Sanoculis Ltd. Israel EUDAMED

Ref A34-000Model MNT2000

EMDN Q020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EIOPMNT2000FB Basic UDI-DIDate23 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903557CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    9 Apr 2025
    Expires
    1 Apr 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MINT Device
Model / Reference
MNT2000, A34-000
Primary DI / UDI-DI
++EIOPA34000
Basic UDI-DI
++EIOPMNT2000FB
Direct Marketing DI
++EIOPA34000
EMDN Code
Q020199 Ophthalmic cutting devices - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000026403
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Sanoculis Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reusable
Other properties (11)
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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 977060ad-ce4e-417f-9427-d03230b10237 61 fields · synced 22 Oct 2026