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Ambu® Oval Plus Silicone Resuscitator

by Ambu A/S Denmark EUDAMED

Ref 370043000Model Ambu® Oval Plus Silicone Resuscitator

EMDN R03020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570748030101031006K 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® Oval Plus Silicone Resuscitator, 370043000
Primary DI / UDI-DI
05707480039937
Basic UDI-DI
570748030101031006K
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa
Medical Purpose
Intended for pulmonary resuscitation

Manufacturer details

EUDAMED SRN
DK-PR-000001946

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 2a61b6fe-5243-4a5f-a7bf-034bd10f8c60 61 fields · synced 23 Oct 2026