Skip to content

iGo2

by DeVilbiss Healthcare LLC 3 variants

Ref 125KSModel 125

iGo2 (125KS) is a Class IIa device made by DeVilbiss Healthcare LLC., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-00885304032977), active as of 23 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00885304032977 Basic UDI-DI 00885304032977UDI-DIDate1 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
iGo2 Portable Oxygen Concentrator
Model / reference
125, 125KS
Primary DI / UDI-DI
00885304032977
Basic UDI-DI
B-00885304032977
EMDN code
Z12159004 Oxygen concentrators
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000021684
Authorised representative
Drive Medical GmbH & Co. KG DE-AR-000044475

Similar devices in this category

Other devices filed under OXYGEN CONCENTRATORS.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

Other properties (12, all answered No)