Skip to content

FOA08MM1606

by OT Bioelettronica srl Italy EUDAMED

Ref OT0323Model ADHESIVE FOAM

EMDN Z12100485

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805697785FOAMSHEET010KP Basic UDI-DIDate20 Apr 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
ADHESIVE FOAM, OT0323
Primary DI / UDI-DI
08056977852571
Basic UDI-DI
805697785FOAMSHEET010KP
Direct Marketing DI
08056977852571
EMDN Code
Z12100485 Electromyography instruments - consumables
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000033348

Other devices from OT Bioelettronica srl

See all devices from OT Bioelettronica srl →

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 37c1b97c-0776-4419-ab03-8830f97956f6 61 fields · synced 22 Oct 2026