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DreamMapper

by Respironics Inc. 2 variants

Ref 1127959

DreamMapper (1127959) is a device classified as Class I in the EU and Class II in the US made by Respironics Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-00606959057715) and listed in FDA GUDID since 3 Sep 2019 (UDI-DI 00606959057715), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959057715 Basic UDI-DI 00606959057715UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959057715 UDI-DI Date3 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00606959057715 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 00606959057715 listed 3 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959057715
  2. Registered EUDAMED B-00606959057715

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  • Withdrawn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
DreamMapper App iOS, APAC EUDAMED
DreamMapper GUDID
Generic name
Self-care monitoring/reporting software
Model / Ref / Catalog
1127959, DreamMapper App iOS, Asia-Pacific Instance - 2
Primary DI / UDI-DI
00606959057715
Basic UDI-DI
B-00606959057715
FDA product code
MNS, BZD, MNT
EMDN code
R03010199 Ventilation masks - other
GMDN term
Self-care monitoring/reporting software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5895, 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1127959
GUDID
DreamMapper App iOS, Asia-Pacific Instance - 2
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Self-care monitoring/reporting software

Similar devices in this category

Other devices filed under VENTILATION MASKS - OTHER.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)