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Assura

by Coloplast A/S 73 variants

Ref 12385

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 Number57089322975228P Basic UDI-DI Date2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780732802 UDI-DI Date2 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  • Withdrawn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

Generic Name
Multiple-piece intestinal ostomy bag, closed-ended
Device Name
Assura/Alterna (New Generation) ostomy bag 2-piece closed
Model / Ref / Catalog
12385
Primary DI / UDI-DI
05701780732802 EUDAMED
05701780673778 EUDAMED
05701780673433 EUDAMED
05701780691062 EUDAMED
05701780688673 EUDAMED
05701780687959 EUDAMED
00762123033883 GUDID
Basic UDI-DI
57089322975228P
Unit of Use DI
05701780086493, 05701780086486, 05701780086530, 05701780086547, 05701780086554, 05708932962674
FDA Product Code
EXB
EMDN Code
A10020202, A10020302
GMDN Term
Multiple-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Ireland
Norway
Denmark
Netherlands
Liechtenstein
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 50 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780732802
05701780673778
05701780673433
05701780691062
05701780688673
05701780687959
GUDID
00762123033883

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