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Biosoft

by Coloplast A/S Denmark EUDAMED

Ref BCAG56

EMDN U020302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893263582188 Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Biosoft duo double loop ureteral stent kit
Model / Reference
BCAG56
Primary DI / UDI-DI
03600040936283
Basic UDI-DI
570893263582188
EMDN Code
U020302 Double loop ureteral stents
Device Class
Class IIb
Medical Purpose
Drainage of the upper urinary tract over fistulas or ureteral obstacles (e.g.: periureteral tumor); Healing of the ureter.

Manufacturer details

EUDAMED SRN
DK-PR-000027597

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 03600040936283|570893263582188 61 fields · synced 24 Oct 2026