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ECG Electrodes

by SORIMEX Sp. z o.o. 24 variants

Ref EK-S 50 P a'2, EK-S 48 PSG, EK-S 60 PSG, EK-S 44 PSG, EK-S 37 P RTG, EGZOTech EE S5540 FWG1, EK-S 50 P, EK-S 60 P, EK-S 50 PSG, EGZOTech EE S5540 FWG, EK-S 25 PSG, EK-1/23 WpHG/2j-L50/RTG, EK-S 45 PSG RTG, EK-S 30 PSG RTG, EK-S 42 PSG a'1, EK-S 22 PSG, EK-1/23 WpHG/2j-L50, EK-S 36 P, EK-S 45 P, EK-S 60 PSG XC, EK-S 45 PSG, EK-S 39 PSG, EK-S 51 P, EK-S 30 PSG, EK-1/23 WpHG/2j-L60Model EK-S, EK-1

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5903002221125B Basic UDI-DI Date11 Jan 2024RegisteredStatusActive

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  • Withdrawn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
Disposable ECG electrodes
disposable ECG electrodes with wire
Model / Reference
EK-S, EK-S 50 P a'2, EK-S 48 PSG, EK-S 60 PSG, EK-S 44 PSG, EK-S 37 P RTG, EGZOTech EE S5540 FWG1, EK-S 50 P, EK-S 60 P, EK-S 50 PSG, EGZOTech EE S5540 FWG, EK-S 25 PSG, EK-1, EK-1/23 WpHG/2j-L50/RTG, EK-S 45 PSG RTG, EK-S 30 PSG RTG, EK-S 42 PSG a'1, EK-S 22 PSG, EK-1/23 WpHG/2j-L50, EK-S 36 P, EK-S 45 P, EK-S 60 PSG XC, EK-S 45 PSG, EK-S 39 PSG, EK-S 51 P, EK-S 30 PSG, EK-1/23 WpHG/2j-L60
Primary DI / UDI-DI
05903002212288, 05903002210895, 05908212623336, 05908212623039, 05903002206539, 05908212624067, 05908212623138, 05908212623312, 05903002214930, 05903002208304, 05908212622896, 05908212624081, 05908212623091, 05908212623831, 05903002214763, 05908212622872, 05908212624074, 05903002217399, 05908212623992, 05903002208397, 05908212623374, 05908212624104, 05908212623152, 05903002205174, 05903002206553, 05908212622919, 05903002202333, 05908212623817, 05903002215821, 05903002210925
Basic UDI-DI
5903002221125B, 5903002221135D
EMDN Code
C020501 ECG electrodes
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000020958

Related devices

Category: Electrocardiographic electrode, single-use

Other devices from SORIMEX Sp. z o.o.

See all devices from SORIMEX Sp. z o.o. →

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