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Coloplast Kids

by Coloplast A/S 17 variants

Ref 18741

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893255584242SQ Basic UDI-DI 05708932713955UDI-DIDate9 Jul 2026RegisteredStatusActive

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  • Withdrawn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
SenSura Mio Kids ostomy set 2-piece
Model / Reference
18741
Primary DI / UDI-DI
05708932713955
Basic UDI-DI
570893255584242SQ
EMDN Code
A1002010401, A10020202, A10020302
Device Class
Class I
Medical Purpose
The ostomy bag is intended to passively collect output from a stoma. The adhesive baseplate is attached to the ostomy bag and is intended to adhere to intact skin around the stoma.

Manufacturer details

EUDAMED SRN
DK-PR-000027597

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Properties

Other properties (1)

  • Sterile: No