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EasyFlex 1-CH

by Bittium Biosignals Oy Finland EUDAMED

Ref S0000033817Model EasyFlex Electrodes EMDN C020501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643003522EasyFlexXD Basic UDI-DIDate6 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EasyFlex Electrodes, S0000033817
Primary DI / UDI-DI
06430035221073
Basic UDI-DI
643003522EasyFlexXD
EMDN Code
C020501 ECG electrodes
Device Class
Class I
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000013983

Other devices from Bittium Biosignals Ltd

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06430035221073|643003522EASYFLEXXD 61 fields · synced 22 Oct 2026