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Ambu® AuraOnce

by Ambu A/S Denmark EUDAMED

Ref 321100000Model Ambu® AuraOnce

EMDN R01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5707480301008001087 Basic UDI-DIDate22 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Ambu® AuraOnce, 321100000
Primary DI / UDI-DI
05707480023134
Basic UDI-DI
5707480301008001087
EMDN Code
R01020101 Laryngeal masks, single-lumen
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001437

Other devices from Ambu A/S

See all devices from Ambu A/S →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 53226537-185e-44b1-ba74-4e2a39b18b2d 61 fields · synced 23 Oct 2026