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Flexima®

by B. Braun Medical SAS 358 variants

Ref 44919FR

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/MDR Number4039239000000108ZH Basic UDI-DI 04046955573660UDI-DIDate17 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Flexima-Softima Uro Silk Cvx pouches
Model / Reference
44919FR
Primary DI / UDI-DI
04046955573660
Basic UDI-DI
4039239000000108ZH
Unit of Use DI
04046955573653
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000674

Other devices from B. Braun Medical SAS

See all devices from B. Braun Medical SAS →

Properties

Other properties (13)

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