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Dansac

by Dansac A/S 490 variants

Part of a family of 26 devices: see the family page

Ref 802-20

Dansac (802-20) is a Class I device made by Dansac A/S, registered in EUDAMED on 3 Sep 2025 (Basic UDI-DI 5709817D02P037S00955X), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5709817D02P037S00955X Basic UDI-DI 05709817606805UDI-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  • Withdrawn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 Closed Ostomy Pouch, GX
Model / reference
802-20
Primary DI / UDI-DI
05709817606805
Basic UDI-DI
5709817D02P037S00955X
Unit of use DI
25709817606809
EMDN code
A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
Device class
Class I
EU registration type
Standard device
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001514

Similar devices in this category

Other devices filed under ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT.

Other devices from Dansac A/S

See all devices from Dansac A/S →

Properties

Other properties (14, all answered No)