MedCare Visions

Device Name

Disposable Sterile EEG Subdermal Needle Electrode

Model / Reference

OL5100046OH, PRO-EBW-NH

Primary DI / UDI-DI

00816022023640

Basic UDI-DI

B-00816022023640

EMDN Code

N01010202 EEG extracranic electrodes

Device Class

Class IIa

Market of Registration

Germany

EUDAMED SRN

US-MF-000036200

Authorised representative

Advena Limited MT-AR-000000234

• The Electrode Store

  Class I

  CE/MDR

• DPNCheck

  Class I

  CE/MDR GUDID on market

• Surface (Cutaneous) Electrode for EMG

  Class II

  CE/MDD CE/MDR +1authorizations

• Protectrode System

  Class II

  FDA 510(k) K926094 Active Cleared 6 Dec 1995

• Protectrode Systems Concentric

  Class II

  FDA 510(k) K932691 Active Cleared 16 Nov 1995

• Surface Electrode for Electroencephalography

  Class II

  FDA 510(k) K022197 Active Cleared 13 Aug 2002

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