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GK247

by Applied Medical Europe B.V. EUDAMED

Active European Union

Ref GK247Model AME STANDARD KIT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607915PPIIA000447 Basic UDI-DIDate23 Jun 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  • Withdrawn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, GK247
Primary DI / UDI-DI
20607915133416
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

Other devices from Applied Medical Europe

See all devices from Applied Medical Europe →

Properties

  • Sterile