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Bus-R-80

by Allium Ltd. Israel EUDAMED

Ref 791-1080Model BUS-R-80

EMDN U0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07290013096630 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Bulbar Urethral Stent (BUS)
Model / Reference
BUS-R-80, 791-1080
Primary DI / UDI-DI
07290013096630
Basic UDI-DI
B-07290013096630
EMDN Code
U0399 Devices for urinary tract dilation - other
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000009302
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Allium Ltd.

See all devices from Allium Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • 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

Sources (1)

  • EUDAMED fe087969-a82d-44bb-8302-2d9054c4e73c 61 fields · synced 22 Oct 2026