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SyncStationBipolar

by OT Bioelettronica srl Italy EUDAMED

Ref OT0266, OT0261Model Adapters

EMDN Z12100780

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805697785ADACTPAS00539 Basic UDI-DIDate21 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Adapters, OT0266, OT0261
Primary DI / UDI-DI
08056977851833, 08056977851840
Basic UDI-DI
805697785ADACTPAS00539
Direct Marketing DI
08056977851833
08056977851840
EMDN Code
Z12100780 EMG telemetry instruments - hardware accessories
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000033348

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 (2)

  • EUDAMED d8536962-2dc7-48f8-b5c0-5f20d8ca20c3 61 fields · synced 22 Oct 2026
  • EUDAMED 08056977851840|805697785ADACTPAS00539 61 fields · synced 19 May 2026