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Nox A1S SAS kit

by Nox Medical Iceland EUDAMED

Ref 513013Model NOX-A1S_SAS

EMDN Z12100501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1569431111NOX_A1SSASKITYY Basic UDI-DIDate21 May 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
Nox A1s System with SAS
Model / Reference
NOX-A1S_SAS, 513013
Primary DI / UDI-DI
15694311112082
Basic UDI-DI
1569431111NOX_A1SSASKITYY
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
System/procedure pack consisting of CE-marked medical device(s) and accessories intended to be used together in accordance with their respective intended purposes.

Manufacturer details

EUDAMED SRN
IS-PR-000054327

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Properties & raw data

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

Sources (1)

  • EUDAMED 04859a5d-08fa-482d-aa3b-dc73740ac06b 61 fields · synced 24 Oct 2026