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Somnibel

by Sibel Sau EUDAMED

Active European Union

Ref 09892

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843603552ADPP00102P8 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Somnibel / Somnibel Pro
Model / Reference
09892
Primary DI / UDI-DI
08436035524006
Basic UDI-DI
843603552ADPP00102P8
Direct Marketing DI
08436035524006
EMDN Code
Z129080 Various instruments for functional exploration and therapeutic interventions - hardware accessories
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000287

Other devices from Sibel Sau

See all devices from Sibel Sau →

Properties

Show properties
  • 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