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Lumed

by Nissha Medical Technologies Ltd 3 variants

Ref ET1166/NIModel Lumed

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50604419ECG-Elec8UQ Basic UDI-DI 15060842920258UDI-DIDate17 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ECG Electrode
Model / Reference
Lumed, ET1166/NI
Primary DI / UDI-DI
15060842920258
Basic UDI-DI
50604419ECG-Elec8UQ, 506044191ECG-Elec8RF
Unit of Use DI
05060842920251
EMDN Code
C020501 ECG electrodes
Device Class
Class I
EU 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

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Properties

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