Skip to content

Sibelsound DUO A

by Sibel Sau Spain EUDAMED

Ref 09132

EMDN Z121401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843603552AAUP00201Q7 Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sibelsound DUO
Model / Reference
09132
Primary DI / UDI-DI
08436035523474
Basic UDI-DI
843603552AAUP00201Q7
Direct Marketing DI
08436035523474
EMDN Code
Z121401 Audiometers
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000287

From the manufacturer

Manufacturer's product page: Sibelsound Duo

Other devices from Sibel Sau

See all devices from Sibel Sau →

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 08436035523474|843603552AAUP00201Q7 61 fields · synced 24 Oct 2026