Skintact

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

Device Name

ECG Electrode

Model / Reference

PD50-SFC

Primary DI / UDI-DI

19005531000220, 19005531000411

Basic UDI-DI

9005531ECGElectrodesCM

Unit of Use DI

09005531000223, 09005531000414

EMDN Code

C020501 ECG electrodes

Device Class

Class I

EU market of registration

Austria

Germany

EUDAMED SRN

AT-MF-000000426

• Skintact

  Class I

  CE/MDR

• megro

  Class I

  CE/MDR

• Skintact and Various Other Tradenames

  Class II

  FDA 510(k) K073104 Active Cleared 16 Nov 2007

• Skintact Radiotransparent Multifunction Electrodes

  Class III

  FDA 510(k) K103186 Active Cleared 8 Feb 2011

• Skintact Multifunction Electrodes, Model DF 21

  Class III

  FDA 510(k) K041883 Active Cleared 7 Sep 2004

• Skintact ECG Electrode

  Class II

  FDA 510(k) K040249 Active Cleared 24 Feb 2004

See all devices from Leonhard Lang GmbH →