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ApWell Nebulization Mask

by Feellife Health Inc. United States EUDAMED

Ref S2Model L2

EMDN R03010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69343253R03010332E78 Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Nebulizati on Mask
Model / Reference
L2, S2
Primary DI / UDI-DI
06934325311852
Basic UDI-DI
69343253R03010332E78
Direct Marketing DI
06934325311852
EMDN Code
R03010301 Aerosol therapy masks
Device Class
Class IIa
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
CN-MF-000000782
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 429f4c07-e3e5-4d13-b692-a541c25091c1 61 fields · synced 22 Oct 2026