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NMT Electrodes, Ag/AgCl Hydrogel Adhesive

by GE Healthcare Finland Oy

Ref 57268-HEL

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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/MDD EUDAMED Number08406821BUG005817K Basic UDI-DI 00840682103633UDI-DIDate24 Mar 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number08406821BUG005817K Basic UDI-DI 00840682103633UDI-DIDate24 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682103633 UDI-DI Date17 Jun 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

1 recall · FDA

    • Terminated Z-1640-2014 FDA Class II initiated 9 Apr 2014

    When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual a

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Analytical non-scalp cutaneous electrode
Device Name
NMT Electrodes, Ag/AgCl Hydrogel Adhesive
Model / Reference
57268-HEL EUDAMED
NMT Electrodes GUDID
Solid Gel GUDID
Ag-AgCl GUDID
Primary DI / UDI-DI
00840682103633
Basic UDI-DI
08406821BUG005817K, B-00840682103633
510(k) Number
FDA Product Code
KOI
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
GMDN Term
Analytical non-scalp cutaneous electrode
Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.2775
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
57268-HEL
GUDID
NMT Electrodes, Solid Gel, Ag-AgCl
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from GE Healthcare Finland Oy

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No