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Dansac

by Dansac A/S 490 variants

Part of a family of 20 devices: see the family page

Ref 4045-25

Dansac (4045-25) is a Class I device made by Dansac A/S, registered in EUDAMED on 3 Sep 2025 (Basic UDI-DI 5709817D02P039S00135V), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5709817D02P039S00135V Basic UDI-DI 05709817608007UDI-DIDate3 Sep 2025RegisteredStatusActive

Official records

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  • Withdrawn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, Convex
Model / reference
4045-25
Primary DI / UDI-DI
05709817608007
Basic UDI-DI
5709817D02P039S00135V
Unit of use DI
25709817608001
EMDN code
A1001010202 One-piece colostomy bags for retracted stoma, convex, with tissue cover
Device class
Class I
EU registration type
Standard device
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001514

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Properties

Other properties (14, all answered No)