Skip to content

Dansac

by Dansac A/S 466 variants

Ref 4083-34

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5709817D02P039S00145X Basic UDI-DI 05709817608038UDI-DIDate3 Sep 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  • Withdrawn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

Device Name
1-Piece Drainable Ostomy Pouch, TRE, Soft Convex
Model / Reference
4083-34
Primary DI / UDI-DI
05709817608038
Basic UDI-DI
5709817D02P039S00145X
Unit of Use DI
25709817608032
EMDN Code
A1001010202 One-piece colostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001514

Other devices from Dansac A/S

See all devices from Dansac A/S →

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