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GK1048

by Applied Medical Europe B.V. EUDAMED

Active European Union

Ref GK1048Model AME STANDARD KIT

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Ame Standard Kit
Model / Reference
AME STANDARD KIT, GK1048
Primary DI / UDI-DI
20607915145914
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

Other devices from Applied Medical Europe

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Properties

  • Sterile