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OMNIbag®

by B. Braun Avitum AG 2 variants

Ref 7211065

OMNIbag® (7211065) is a Class I device made by B.Braun Avitum AG, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 40392390000023372K), active as of 7 Nov 2026.

Active European Union

CE MDR

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/MDR Number40392390000023372K Basic UDI-DI 04046964580222UDI-DIDate2 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
OMNIbag Is
Model / reference
7211065
Primary DI / UDI-DI
04046964580222
Basic UDI-DI
40392390000023372K
EMDN code
F90040101 Haemodialysate collection bags
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005127

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Properties

  • Supplied sterile
Other properties (13, all answered No)