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iGo2

by DeVilbiss Healthcare LLC 3 variants

Ref 125K-BT-XB

iGo2 (125K-BT-XB) is a Class IIa device made by DeVilbiss Healthcare LLC., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00885304033240), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00885304033240 Basic UDI-DI 00885304033240UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Portable Oxygen Concentrator
Model / reference
125K-BT-XB
Primary DI / UDI-DI
00885304033240
Basic UDI-DI
B-00885304033240
EMDN code
R060202 Oxygen administration humidification systems
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 ADMINISTRATION HUMIDIFICATION SYSTEMS.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

Other properties (12, all answered No)