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SensoDetect® BERA System

by Sensodetect AB Sweden EUDAMED

Ref A1000-4 EMDN Z12140301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735017021SensoDetectZA Basic UDI-DIDate12 Nov 2024RegisteredStatusActive

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  • Withdrawn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
A1000-4
Primary DI / UDI-DI
07350170210000
Basic UDI-DI
735017021SensoDetectZA
EMDN Code
Z12140301 Evoked potential audiometry integrated systems
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000017761

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 737625b9-f5df-4e58-83d1-fd434e400be5 61 fields · synced 22 Oct 2026