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Oxi2 Plus

by Modül Grup Mühendislik Elektr.Med.İnş.Eğt.ve Bilş.San.Tic.Ltd.Şti.

Ref Oxivent Oxi2 PlusModel Oxi2 Plus

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680829050312 Basic UDI-DI 08680829050312UDI-DIDate25 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Portable Lung Ventilator
Model / Reference
Oxi2 Plus, Oxivent Oxi2 Plus
Primary DI / UDI-DI
08680829050312
Basic UDI-DI
B-08680829050312
EMDN Code
Z12030104 Portable pulmonary ventilators
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000050023

Other devices from Modül Grup Mühendislik Elektr.Med.İnş.Eğt.ve Bilş.San.Tic.Ltd.Şti.

See all devices from Modül Grup Mühendislik Elektr.Med.İnş.Eğt.ve Bilş.San.Tic.Ltd.Şti. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No