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ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Paediatric Standard)

by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) 2 variants

Ref 2004-02Model ULTRAMED OXYGEN FACE MASK, ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Paediatric Standard)

Active European Union

CE MDR CE MDD

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/MDD Number622300425OFM2004TL Basic UDI-DI 06223004251610UDI-DIDate16 Mar 2026RegisteredStatusActive
European UnionCE/MDR Number622300425OFM2004TL Basic UDI-DI 06223004251610UDI-DIDate16 Mar 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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
Ultramed Oxygen Face Mask
Model / Reference
ULTRAMED OXYGEN FACE MASK, 2004-02, ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Paediatric Standard)
Primary DI / UDI-DI
06223004251610
Basic UDI-DI
622300425OFM2004TL, B-06223004251610
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
EG-MF-000038562
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)

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Properties

  • 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