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Ancillary EMG, EEG &/or IOM Cables

by Natus Neurology Incorporated 12 variants

Ref 085-417401

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038283NA00013DU Basic UDI-DI 00382830058247UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830058247 UDI-DI Date14 Sep 2021ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Natus
Generic Name
Analytical non-scalp cutaneous lead
Device Name
Ancillary EMG, EEG &/or IOM Cables
Model / Reference
085-417401
Primary DI / UDI-DI
00382830058247
Basic UDI-DI
038283NA00013DU
FDA Product Code
IKD
EMDN Code
V9015 Electrodes and probes cutaneous conductive substances
GMDN Term
Analytical non-scalp cutaneous lead
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1175
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No