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Coloplast

by Coloplast A/S

Ref 14204

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number570893229758095 Basic UDI-DI Date4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780983815 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Coloplast EUDAMED
Assura GUDID
Generic Name
Multiple-piece urostomy bag, open-ended
Device Name
Assura/Alterna/Coloplast (Original) urostomy 2-piece microbag
Model / Ref / Catalog
14204
Primary DI / UDI-DI
05701780983815 EUDAMED
05708932224789 EUDAMED
05701780959391 EUDAMED
05708932331159 EUDAMED
00762123042861 GUDID
Basic UDI-DI
570893229758095
Unit of Use DI
05701780103466, 05708932961547, 05701780103350, 05701780103398
FDA Product Code
EXB
EMDN Code
A10020402 Urostomy bags for two-part systems, with tissue cover
GMDN Term
Multiple-piece urostomy bag, open-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Denmark
Germany
Belgium
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780983815
05708932224789
05701780959391
05708932331159
GUDID
00762123042861

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No