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Resuscitation Mask Large Infant

by GaleMed Corporation 2 variants

Ref XTF0028Model (O) Mask

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471081008RNOMAP Basic UDI-DI 44026704615719UDI-DIDate7 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Reusable Silicone Mask
Model / Reference
(O) Mask, XTF0028
Primary DI / UDI-DI
44026704615719
Basic UDI-DI
471081008RNOMAP
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

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

Other devices from GaleMed Corporation

See all devices from GaleMed Corporation →

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