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Hyper-Box System, Austria

by AOTI Limited Ireland EUDAMED

Ref G00001-2-AUT, G00001-2-AUSModel Hyper-Box System

EMDN A99

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05391518740980 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 24 Oct 2026

Trade Name
Hyper-Box System, Austria
Hyper-Box System, Australia
Model / Reference
Hyper-Box System, G00001-2-AUT, G00001-2-AUS
Primary DI / UDI-DI
05391518740980, 05391518741031
Basic UDI-DI
B-05391518740980, B-05391518741031
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class IIa
Market of Registration
Austria
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000025075

Other devices from Aoti, Ltd.

See all devices from Aoti, Ltd. →

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 (2)

  • EUDAMED ad54b3e1-70cc-4016-b6e4-e5697c6f7e06 61 fields · synced 24 Oct 2026
  • EUDAMED 05391518741031|B-05391518741031 61 fields · synced 2 Aug 2026