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Oxygen Mask Adult

by GPC Medical Limited

Ref DIS 104a

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 Number890605246GPCOMFT Basic UDI-DI 08906052460125UDI-DIDate7 Feb 2025RegisteredStatusActive

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  • Withdrawn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
External Ventilation System – Oxygen Mask
Model / Reference
DIS 104a
Primary DI / UDI-DI
08906052460125
Basic UDI-DI
890605246GPCOMFT
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000014414
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Gpc Medical, Ltd.

See all devices from Gpc Medical, Ltd. →

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