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GK261

by Applied Medical Europe B.V. Netherlands EUDAMED

Ref GK261Model AME STANDARD KIT

EMDN K010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607915PPIIA000447 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, GK261
Primary DI / UDI-DI
20607915134925
Basic UDI-DI
0607915PPIIA000447
EMDN Code
K010102 Minimally invasive surgery kits, single-use
Device Class
Class IIa
Medical Purpose
To gain access for minimally invasive surgical procedures and to deliver sterile irrigation fluids and to evacuate blood, tissue debris and smoke from the surgical site.

Manufacturer details

EUDAMED SRN
NL-PR-000024031

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 20607915134925|0607915PPIIA000447 61 fields · synced 24 Oct 2026