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Lumed

by Nissha Medical Technologies Ltd United Kingdom EUDAMED

Ref ET4136/NIModel Lumed

EMDN C020501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50604419ECG-Elec8UQ Basic UDI-DIDate17 Jul 2025RegisteredStatusActive

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
ECG Electrode
Model / Reference
Lumed, ET4136/NI
Primary DI / UDI-DI
15060842920265
Basic UDI-DI
50604419ECG-Elec8UQ, 506044191ECG-Elec8RF
Unit of Use DI
05060842920268
EMDN Code
C020501 ECG electrodes
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
GB-MF-000012057
Authorised representative
NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795

Related devices

Category: Electrocardiographic electrode, single-use

Other devices from Nissha Medical Technologies Ltd

See all devices from Nissha Medical Technologies Ltd →

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 (2)

  • EUDAMED 2faea11f-9aad-45f7-9b22-1c4c94d3cea4 61 fields · synced 22 Oct 2026
  • EUDAMED 15060842920265|506044191ECG-ELEC8RF 61 fields · synced 22 Oct 2026