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Esteem Synergy+

by ConvaTec Limited 16 variants

Ref 416774Model Two 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number768455OST0037FJ Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
Two Piece Pouch Faecal
Model / Reference
Two Piece Pouch Faecal, 416774
Primary DI / UDI-DI
00768455114931
Basic UDI-DI
768455OST0037FJ
EMDN Code
A10020201 Colostomy bags for two-part systems, 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