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HD20MM1602B

by OT Bioelettronica srl Italy EUDAMED

Ref OT0288, OT0321Model ELECTRODES ARRAY, Accessories

EMDN N010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805697785ELECARRAY009C6 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

Trade Name
HD20MM1602B
HD20MM1602B Cover
Model / Reference
ELECTRODES ARRAY, OT0288, Accessories, OT0321
Primary DI / UDI-DI
08056977852007, 08056977852557
Basic UDI-DI
805697785ELECARRAY009C6, 805697785MECHPART007J6
Direct Marketing DI
08056977852007
08056977852557
EMDN Code
N010101, Z12100785
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 (2)

  • EUDAMED 6e640138-b2e7-4a6b-86e4-af95f72b3fe7 61 fields · synced 22 Oct 2026
  • EUDAMED 08056977852557|805697785MECHPART007J6 61 fields · synced 16 May 2026