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Sistema Somnibel

by Sibel Sau EUDAMED

Active European Union

Ref 09892-S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843603552ADPY00102SV Basic UDI-DIDate29 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  • Withdrawn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
Sistema Somnibel / Somnibel Pro
Model / Reference
09892-S
Primary DI / UDI-DI
08436035524198
Basic UDI-DI
843603552ADPY00102SV
EMDN Code
Z129080 Various instruments for functional exploration and therapeutic interventions - hardware accessories
Device Class
Class IIa
Medical Purpose
Treatment of positional Obstructive Sleep Apnea (OSA) or positional snoring.

Manufacturer details

EUDAMED SRN
ES-PR-000052577

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Properties

Show properties
Other properties (1)
  • Sterile: No