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Sleepware G3 Software, Multi-Lingual - 3

by Respironics Inc.

Ref 1082463

Sleepware G3 Software, Multi-Lingual - 3 (1082463) 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-00606959045262) and listed in FDA GUDID since 10 Oct 2017 (UDI-DI 00606959045262), 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-00606959045262 Basic UDI-DI 00606959045262UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959045262 UDI-DI Date10 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00606959045262 registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 00606959045262 listed 10 Oct 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959045262
  2. Registered EUDAMED B-00606959045262

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  • Withdrawn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
Sleepware G3 Software Package_ML EUDAMED
Sleepware GUDID
Generic name
Polysomnography analyser
Model / Ref / Catalog
1082463, Sleepware G3 Software, Multi-Lingual - 3, 3.8
Primary DI / UDI-DI
00606959045262, 00606959004856
Basic UDI-DI
B-00606959045262
FDA product code
OLZ
EMDN code
Z12100582 Polysomnography instruments - software accessories
GMDN term
Polysomnography analyser
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
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
1082463
GUDID
Sleepware G3 Software, Multi-Lingual - 3
3.8
Device classEUDAMED
Class IIa
GUDID
Class II

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: Polysomnography analyser

Similar devices in this category

Other devices filed under POLYSOMNOGRAPHY INSTRUMENTS.

Other devices from Respironics Inc.

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Properties

  • Prescription use
  • HCT/P YesGUDIDNoGUDID
  • Lot / batch number
Other properties (22, all answered No)