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Lenire

by Neuromod Devices Limited United States EUDAMED

Ref EU1Model SM-301

EMDN Z12149099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539154058SM-301-EU1XE Basic UDI-DIDate25 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SM-301, EU1
Primary DI / UDI-DI
05391540580035
Basic UDI-DI
539154058SM-301-EU1XE
Direct Marketing DI
05391540580035
EMDN Code
Z12149099 Various ENT instruments - other
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000004261

Other devices from Neuromod Devices Limited

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 85d25078-57b1-4d1f-ba20-16492f8c9bbc 61 fields · synced 24 Oct 2026