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Hyper-Box System, Poland

by AOTI Limited Ireland EUDAMED

Ref G00001-2-POLModel Hyper-Box System

EMDN A99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05391518740850 Basic UDI-DIDate27 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Hyper-Box System, G00001-2-POL
Primary DI / UDI-DI
05391518740850
Basic UDI-DI
B-05391518740850
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
IE-MF-000025075

Other devices from AOTI Limited

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Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 7b1696be-b3e8-4003-bed2-995b90a560a3 61 fields · synced 22 Oct 2026