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Biosoft BCAF77

by Coloplast A/S

Ref BCAS85

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number570893263582188 Basic UDI-DI 03600040940754UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040940754 UDI-DI Date12 Apr 2024ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Biosoft EUDAMEDGUDID
Porges Coloplast GUDID
Generic Name
Urological surgical procedure kit, non-medicated, single-use
Polymeric ureteral stent
Device Name
Biosoft duo double loop ureteral stent kit
Model / Ref / Catalog
BCAS85, BCAF77
Primary DI / UDI-DI
03600040940754 EUDAMED
05701780337106 GUDID
05708932061599 GUDID
Basic UDI-DI
570893263582188
FDA Product Code
FAD
EMDN Code
U020302 Double loop ureteral stents
GMDN Term
Urological surgical procedure kit, non-medicated, single-use
Polymeric ureteral stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4620
Medical Purpose
Drainage of the upper urinary tract over fistulas or ureteral obstacles (e.g.: periureteral tumor); Healing of the ureter.
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Length — 22 Centimeter
Catheter Gauge — 7 French
Catheter Gauge — 8 French
Length — 28 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03600040940754
GUDID
05701780337106
05708932061599
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Urological surgical procedure kit, non-medicated, single-use

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Implantable NoGUDIDYesGUDID
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No