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Esteem+

by ConvaTec Limited 27 variants

Ref 422457Model One Piece Pouch Faecal

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number768455OST0038FL Basic UDI-DI 00768455168521UDI-DIDate9 Oct 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
One Piece Pouch Faecal
Model / Reference
One Piece Pouch Faecal, 422457
Primary DI / UDI-DI
00768455168521
Basic UDI-DI
768455OST0038FL
EMDN Code
A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000001770
Authorised representative
Unomedical A/S DK-AR-000000941

Other devices from Convatec Limited

See all devices from Convatec Limited →

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