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Biosoft

by Coloplast A/S 286 variants

Ref BCAD42

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 Number570893263582188 Basic UDI-DI 03600040934036UDI-DIDate7 Sep 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  • Withdrawn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
Biosoft duo double loop ureteral stent kit
Model / Reference
BCAD42
Primary DI / UDI-DI
03600040934036
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

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Properties

  • Sterile