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Nebulizer Mask

by Ningbo Trustlab Instruments Co., Ltd. China EUDAMED

Ref GT012-100Model Adult XL, Pediatric M EMDN R03010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06973351317315 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Adult XL, GT012-100, Pediatric M
Primary DI / UDI-DI
06973351317315, 06973351317322
Basic UDI-DI
B-06973351317315, B-06973351317322
EMDN Code
R03010301 Aerosol therapy 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
  • Administering Medicine NoEUDAMEDYesEUDAMED
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED b087afe6-6fea-4c63-a6c5-4cbfbb7ae4fc 61 fields · synced 25 Oct 2026
  • EUDAMED 06973351317322|B-06973351317322 61 fields · synced 3 Aug 2026