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Assura 2501

by Coloplast A/S

Ref 2501

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322975178W Basic UDI-DI 05701780485012UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780485012 UDI-DI Date17 Jan 2023ListedStatusListed 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  • Withdrawn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
Assura
Generic Name
One-piece intestinal ostomy bag, closed-ended
Device Name
Assura/Alterna (Original) ostomy bag 1-piece minicap
Model / Ref / Catalog
2501
Primary DI / UDI-DI
05701780485012 EUDAMED
00762123020388 GUDID
Basic UDI-DI
57089322975178W
Unit of Use DI
05701780424264
FDA Product Code
EXB
EMDN Code
A100104 Expansion caps for abdominal ostomy systems - one piece
GMDN Term
One-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780485012
GUDID
00762123020388

Related devices

Category: One-piece intestinal ostomy bag, closed-ended

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