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Ambu® Oval Plus Silicone Resuscitator

by Ambu A/S Denmark EUDAMED

Ref A288201000Model Oval Plus Silicone Resuscitator, Reservoir Bag

EMDN R03020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5707480301005500086 Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Oval Plus Silicone Resuscitator, Reservoir Bag
Model / Reference
Oval Plus Silicone Resuscitator, Reservoir Bag, A288201000
Primary DI / UDI-DI
05707480037261
Basic UDI-DI
5707480301005500086
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001437

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 a1796543-ef03-4856-babb-d88eb69bd028 61 fields · synced 24 Oct 2026