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VersaTrode

by Nissha Medical Technologies Ltd 24 variants

Ref FW55Model VersaTrode

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 Number506044191ECG-Elec2R3 Basic UDI-DI 05060441914149UDI-DIDate1 Nov 2023RegisteredStatusActive

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  • Withdrawn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
VersaTrode, FW55
Primary DI / UDI-DI
05060441914149
Basic UDI-DI
506044191ECG-Elec2R3
EMDN Code
C020501 ECG electrodes
Device Class
Class I
EU market of registration
France

Manufacturer details

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

Other devices from Nissha Medical Technologies Ltd

See all devices from Nissha Medical Technologies Ltd →

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