Skip to content

Uniblocker

by Fuji Systems Corporation, Shirakawa Plant 2 variants

Ref 1303105Model 5.0FR

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number45440501071KU Basic UDI-DI 04544050123044UDI-DIDate8 Jul 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Endobronchial Tube
Model / Reference
5.0FR, 1303105
Primary DI / UDI-DI
04544050123044
Basic UDI-DI
45440501071KU
EMDN Code
R010403 Endobronchial blockers
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
JP-MF-000006591
Authorised representative
MedDevConsult GmbH DE-AR-000005877

Other devices from Fuji Systems Corporation, Shirakawa Plant

See all devices from Fuji Systems Corporation, Shirakawa Plant →

Properties

  • Sterile

Other properties (12)

  • 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