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OxyMulti-Mask™ Plus with Nebulizer

by Southmedic Inc.

Ref OPMK-4025-8Model Many

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6209741423241341BM Basic UDI-DI 10620974004476UDI-DIDate11 Jun 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  • Withdrawn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
OxyMulti-Mask™ with Nebulizer
Model / Reference
Many, OPMK-4025-8
Primary DI / UDI-DI
10620974004476
Basic UDI-DI
6209741423241341BM
EMDN Code
R03010301 Aerosol therapy masks
Device Class
Class IIa
Medical Purpose
A minimal contact, open oxygen delivery device for use with USP medical grade oxygen and delivery of aerosolized drug therapy or high humidity therapy.

Manufacturer details

EUDAMED SRN
CA-PR-000013764

Other devices from Southmedic, Inc.

Properties

Other properties (1)

  • Sterile: No