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GK1043

by Applied Medical Europe B.V. Netherlands EUDAMED

Ref GK1043Model AME STANDARD KIT

EMDN K010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607915PPIIA00074D Basic UDI-DIDate23 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

Device Name
Ame Standard Kit
Model / Reference
AME STANDARD KIT, GK1043
Primary DI / UDI-DI
20607915145716
Basic UDI-DI
0607915PPIIA00074D
EMDN Code
K010102 Minimally invasive surgery kits, single-use
Device Class
Class IIa
Medical Purpose
To enable a laparoscopic approach before and after specimen retrieval through a wound protector-retractor.

Manufacturer details

EUDAMED SRN
NL-PR-000024031

Other devices from Applied Medical Europe

See all devices from Applied Medical Europe →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 20607915145716|0607915PPIIA00074D 61 fields · synced 24 Oct 2026