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Mapelson Breathing Unit, sterile

by Covidien llc United States EUDAMED

Ref 309/6310

EMDN R03020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B00029228K Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Mapelson Breathing Unit, sterile
Model / Reference
309/6310
Primary DI / UDI-DI
10884522022514
Basic UDI-DI
0763000B00029228K
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000028763
Authorised representative
Medtronic B.V. NL-AR-000006050

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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 10884522022514|0763000B00029228K 61 fields · synced 25 Oct 2026