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Sistema Somnibel Pro

by Sibel Sau Spain EUDAMED

Ref 09893-S EMDN Z129080

Regulatory status

as of 25 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Sistema Somnibel / Somnibel Pro
Model / Reference
09893-S
Primary DI / UDI-DI
08436035524204
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

From the manufacturer

Manufacturer's product page: Somnibel

Other devices from Sibel Sau

See all devices from Sibel Sau →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 9a0f90c2-e938-4065-997e-99574f5daeb2 61 fields · synced 24 Oct 2026