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Cortical Stimulator Unit

by Natus Neurology Incorporated

Ref 982A0558

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038283NA00027E7 Basic UDI-DI 00382830032919UDI-DIDate9 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Nicolet Cortical Stimulator
Model / Reference
982A0558
Primary DI / UDI-DI
00382830032919
Basic UDI-DI
038283NA00027E7
EMDN Code
Z12101102 Electrode positioning systems for brain stimulation
Device Class
Class IIb
EU 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

  • Measuring Function

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
  • Administering Medicine: No
  • Incorporates Medicinal Product: No