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Assura

by Coloplast A/S 73 variants

Ref 12135

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 Number57089322975208K Basic UDI-DI Date1 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780628167 UDI-DI Date11 Mar 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  • Withdrawn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
One-piece intestinal ostomy bag, closed-ended
Device Name
Assura/Alterna (New Generation) ostomy bag 1-piece closed
Model / Ref / Catalog
12135
Description
Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Transparent. Midi. Midi. Base Plate Precut Start Hole Size 30 mm, Base Plate Type Flat.
Primary DI / UDI-DI
05701780628167 EUDAMED
05701780715256 EUDAMED
05701780643443 EUDAMED
00762123033685 GUDID
Basic UDI-DI
57089322975208K
Unit of Use DI
05708932963053, 05701780081962, 05701780082020
FDA Product Code
EXB
EMDN Code
A1001010102, A1001020102
GMDN Term
One-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Germany
Denmark
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780628167
05701780715256
05701780643443
GUDID
00762123033685

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