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JOYCEone Full Face, JOYCEone Full Face NV, oMnia Full Face

by Löwenstein Medical Technology GmbH + Co. KG 16 variants

Ref WM 25270EG0

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4050384JOYCEoneFullFace8A Basic UDI-DI 04050384313759UDI-DIDate20 Oct 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
JOYCEone Full Face, JOYCEone Full Face NV, oMnia Full Face
Model / Reference
WM 25270EG0
Primary DI / UDI-DI
04050384313759
Basic UDI-DI
4050384JOYCEoneFullFace8A
Direct Marketing DI
04050384313759
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
DE-MF-000006010

Other devices from Löwenstein Medical Technology GmbH + Co. KG

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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