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EDX 8 channel Amplifier

by Natus Neurology Incorporated

Ref 842-692300, 515-016200

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number038283NA00151E9 Basic UDI-DI Date15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830033640 UDI-DI Date16 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
EDX 8 channel Amplifier EUDAMED
EDX 8 channel Amplifier 0162 EUDAMED
Natus GUDID
Generic Name
Electromyograph
Device Name
Nicolet EDX
Model / Reference
842-692300, 515-016200
Primary DI / UDI-DI
00382830033640, 00382830037303
Basic UDI-DI
038283NA00151E9
Direct Marketing DI
00382830033640
00382830037303
510(k) Number
FDA Product Code
IKN
EMDN Code
Z12100401 Electromyographs
GMDN Term
Electromyograph
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
890.1375
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
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
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No