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Coloplast

by Coloplast A/S 84 variants

Ref 2807

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975799L Basic UDI-DI Date4 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Coloplast
Alterna
Device Name
Assura/Alterna/Coloplast (Original) urostomy 2-piece minicap
Model / Reference
2807
Primary DI / UDI-DI
05701780847612, 05701780843089, 05701780952804, 05701780874182, 05701780792332, 05701780843041
Basic UDI-DI
57089322975799L
Unit of Use DI
05701780024358, 05701780024471, 05701780024396, 05701780024419, 05701780024365, 05708932966177
EMDN Code
A10020402 Urostomy bags for two-part systems, with tissue cover
Device Class
Class I
EU market of registration
Netherlands
Liechtenstein
Belgium
Ireland
Denmark
Germany

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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Properties

Other properties (13)

  • 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