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i-Cut

by A.M.I. Agency for Medical Innovations GmbH United States EUDAMED

Ref ICT5011

EMDN Z12080299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EAMIA47B4C1D2NR Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ICT5011
Primary DI / UDI-DI
+EAMIICT50110
Basic UDI-DI
++EAMIA47B4C1D2NR
EMDN Code
Z12080299 Gynaecology and fertility treatment instruments - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AT-MF-000016792

Other devices from A.M.I. Agency for Medical Innovations GmbH

See all devices from A.M.I. Agency for Medical Innovations GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: 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 +EAMIICT50110|++EAMIA47B4C1D2NR 61 fields · synced 24 Oct 2026