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GK1095

by Applied Medical Europe B.V. EUDAMED

Active European Union

Ref GK1095Model AME STANDARD KIT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607915PPIIA000243 Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Ame Standard Kit
Model / Reference
AME STANDARD KIT, GK1095
Primary DI / UDI-DI
20607915146997
Basic UDI-DI
0607915PPIIA000243
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 retrieve specimen.

Manufacturer details

EUDAMED SRN
NL-PR-000024031

Other devices from Applied Medical Europe

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Properties

  • Sterile