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Simple Oxygen Mask

by Ningbo Trustlab Instruments Co., Ltd. China EUDAMED

Ref GT012-110 Model Adult XL

EMDN R03010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06973351317339 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Oxygen Mask
Model / Reference
Adult XL, GT012-110
Primary DI / UDI-DI
06973351317339
Basic UDI-DI
B-06973351317339
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000008493
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Trustlab Instruments Co., Ltd.

See all devices from Ningbo Trustlab Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 54df00af-5c04-469e-8cd2-46adb64ee37d 61 fields · synced 24 Oct 2026