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Nebulizer

by Salter Labs, LLC United States EUDAMED

Ref 8901-0-50Model Salter Nebulizers

EMDN R060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607411TF20013d_NebEE Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

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
Salter Nebulizers, 8901-0-50
Primary DI / UDI-DI
10607411890069
Basic UDI-DI
0607411TF20013d_NebEE
Unit of Use DI
00607411890062
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000007934
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

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 10607411890069|0607411TF20013D_NEBEE 61 fields · synced 24 Oct 2026