Skip to content

Assura

by Coloplast A/S 73 variants

Ref 12841

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number570893229760994 Basic UDI-DI Date12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780603096 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  • Withdrawn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
Intestinal ostomy base plate, flat
Device Name
Assura/Alterna (Original) ostomy baseplate
Model / Ref / Catalog
12841
Primary DI / UDI-DI
05701780603096 EUDAMED
05701780607018 EUDAMED
05701780702980 EUDAMED
05701780607162 EUDAMED
00762123020777 GUDID
Basic UDI-DI
570893229760994
Unit of Use DI
05701780090575, 05708932962391, 05701780090599, 05701780090421
FDA Product Code
EXB
EMDN Code
A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
GMDN Term
Intestinal ostomy base plate, flat
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Denmark
Germany
Netherlands
Liechtenstein
GUDID distribution status
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
05701780603096
05701780607018
05701780702980
05701780607162
GUDID
00762123020777

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