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DreamStation

by Respironics Inc. 123 variants

Ref AUX500T15

DreamStation (AUX500T15) is a device classified as Class IIa in the EU and Class II in the US made by Respironics Inc., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI B-00606959424616) and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00606959424616), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959424616 Basic UDI-DI 00606959424616UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959424616 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00606959424616 registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 00606959424616 listed 7 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959424616
  2. Registered EUDAMED B-00606959424616

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
DreamStation Auto CPAP w/Humid w/H Tube, AU EUDAMED
DreamStation GUDID
Generic name
Home CPAP unit
Model / Ref / Catalog
AUX500T15, DreamStation Auto CPAP w/Humid w/H Tube, AU
Primary DI / UDI-DI
00606959424616 EUDAMED
00606959026018 GUDID
Basic UDI-DI
B-00606959424616
FDA product code
BZD
EMDN code
Z12030102 Continuous positive pressure equipment
GMDN term
Home CPAP unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5905
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AUX500T15
GUDID
DreamStation Auto CPAP w/Humid w/H Tube, AU
Primary DI / UDI-DIEUDAMED
00606959424616
GUDID
00606959026018
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00606959424616; FDA GUDID lists 00606959026018), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Home CPAP unit

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)