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Adj PEEP Valve, 2-10cmH2O, 30F, PSF

by GaleMed Corporation EUDAMED

Active European Union

Ref AV0035Model (L) Resuscitator

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471081008RNL48W Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Reusable PEEP Valve
Model / Reference
(L) Resuscitator, AV0035
Primary DI / UDI-DI
44710810083653
Basic UDI-DI
471081008RNL48W
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000022411
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Show properties
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