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Natus Elite - Keypoint Reader Software

by Natus Neurology Incorporated United States EUDAMED

Ref 828-069600

EMDN Z12100482

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038283NA00151E9 Basic UDI-DIDate15 Apr 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
Nicolet EDX
Model / Reference
828-069600
Primary DI / UDI-DI
00382830044462
Basic UDI-DI
038283NA00151E9
EMDN Code
Z12100482 Electromyography instruments - software accessories
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000004246
Authorised representative
Natus Manufacturing Ltd IE-AR-000000884

Other devices from Natus Neurology Incorporated

See all devices from Natus Neurology Incorporated →

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 84bdd1f8-0187-4fef-9fbf-36f5bb9ec293 61 fields · synced 22 Oct 2026