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Somfit Pro Disposable ECG Electrode

by Compumedics Limited

Ref 7037-1006-00

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 Number9342451ELECTRODEEH Basic UDI-DI 09342451007728UDI-DIDate5 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Somfit Electrode with Prep Pad
Model / Reference
7037-1006-00
Primary DI / UDI-DI
09342451007728
Basic UDI-DI
9342451ELECTRODEEH
EMDN Code
Z12100585 Polysomnography instruments - consumables
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000050437
Authorised representative
Compumedics EUROPE GmbH DE-AR-000039096

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See all devices from Compumedics Limited →

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