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Sistema Screen&Go

by Sibel Sau EUDAMED

Active European Union

Ref 09895-S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843603552APOY00102ZG 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  • Withdrawn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 Screen&Go / Sleep&Go
Model / Reference
09895-S
Primary DI / UDI-DI
08436035524211
Basic UDI-DI
843603552APOY00102ZG
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
Simplified diagnosis of the apnea and hypopnea syndrome."

Manufacturer details

EUDAMED SRN
ES-PR-000052577

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Properties

Show properties
Other properties (1)
  • Sterile: No