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Assura

by Coloplast A/S 73 variants

Ref 2845

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number570893291026072 Basic UDI-DI Date15 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780718806 UDI-DI Date2 Dec 2022ListedStatusListed GUDID: not 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  • Withdrawn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, open-ended, single-use
Device Name
Assura/Alterna Magnum high output ileostomy bag (2-piece open)
Model / Ref / Catalog
2845
Primary DI / UDI-DI
05701780718806 EUDAMED
05701780719049 EUDAMED
05701780637992 EUDAMED
00762123049631 GUDID
Basic UDI-DI
570893291026072
Unit of Use DI
05708932966030, 05701780026963, 05701780026932
FDA Product Code
EXB
EMDN Code
A10020302, A108099
GMDN Term
Multiple-piece intestinal ostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Germany
Liechtenstein
Netherlands
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 40 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780718806
05701780719049
05701780637992
GUDID
00762123049631

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