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Oxygen Mask

by Ningbo Great Mountain Medical Instruments Co., Ltd 3 variants

Ref GM-001-001Model Rebreathing Mask

Active European Union

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06972527413240 Basic UDI-DI Date15 Sep 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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Oxygen Mask
Model / Reference
Rebreathing Mask, GM-001-001
Primary DI / UDI-DI
06972527413240, 06972527413257, 06972527413196, 06972527413233
Basic UDI-DI
B-06972527413240, B-06972527413257, B-06972527413196, B-06972527413233
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033311
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Other devices from Ningbo Great Mountain Medical Instruments Co., Ltd

See all devices from Ningbo Great Mountain Medical Instruments Co., Ltd →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No