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iGo2 125K

by DeVilbiss Healthcare LLC.

Ref 125K

iGo2 125K is a device classified as Class IIa in the EU and Class II in the US made by DeVilbiss Healthcare LLC., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00885304022244) and listed in FDA GUDID since 1 May 2019 (UDI-DI 00885304022244), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885304022244 Basic UDI-DI 00885304022244UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885304022244 UDI-DI Date1 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00885304022244 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00885304022244 listed 1 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00885304022244
  2. Registered EUDAMED B-00885304022244

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  • Withdrawn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
iGo2
Generic name
Mobile/portable oxygen concentrator
Model / Ref / Catalog
125K
Primary DI / UDI-DI
00885304022244
Basic UDI-DI
B-00885304022244
FDA product code
CAW
EMDN code
R060202 Oxygen administration humidification systems
GMDN term
Mobile/portable oxygen concentrator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5440
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Mobile/portable oxygen concentrator

Similar devices in this category

Other devices filed under OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)