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GK291

by Applied Medical Europe B.V. Netherlands EUDAMED

Ref GK291Model AME STANDARD KIT

EMDN K010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607915PPIIB00094U Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Ame Standard Kit
Model / Reference
AME STANDARD KIT, GK291
Primary DI / UDI-DI
20607915136332
Basic UDI-DI
0607915PPIIB00094U
EMDN Code
K010102 Minimally invasive surgery kits, single-use
Device Class
Class IIb
Medical Purpose
To gain access for minimally invasive surgical procedures and to mobilize and/or transect tissue.

Manufacturer details

EUDAMED SRN
NL-PR-000024031

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 20607915136332|0607915PPIIB00094U 61 fields · synced 23 Oct 2026