Skip to content

Dansac

by Dansac A/S 490 variants

Ref 862-15

Dansac (862-15) is a Class I device made by Dansac A/S, registered in EUDAMED on 3 Sep 2025 (Basic UDI-DI 5709817D02P039S001765), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5709817D02P039S001765 Basic UDI-DI 05709817355031UDI-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  • Withdrawn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, GX, Convex X3
Model / reference
862-15
Primary DI / UDI-DI
05709817355031
Basic UDI-DI
5709817D02P039S001765
Unit of use DI
05709817379846
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

Related devices

Category: One-piece intestinal ostomy bag, closed-ended

Similar devices in this category

Other devices filed under ONE PIECE COLOSTOMY BAGS.

Other devices from Dansac A/S

See all devices from Dansac A/S →

Properties

Other properties (14, all answered No)