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Coloplast Baby

by Coloplast A/S

Ref 18740

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893255584245SW Basic UDI-DI 05708932714037UDI-DIDate5 Nov 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SenSura Mio Baby ostomy set 2-piece
Model / Reference
18740
Primary DI / UDI-DI
05708932714037
Basic UDI-DI
570893255584245SW
EMDN Code
A1002010401, A10020201, A10020301
Device Class
Class IIa
Medical Purpose
The ostomy bag is intended to collect output from a stoma. The adhesive is intended to fix the bag and adhere to intact skin around the stoma(s). Sterile ostomy bag for facilitation of mucous fistula refeeding of the descending stoma with output collected from the ostomy bag.

Manufacturer details

EUDAMED SRN
DK-PR-000027597

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Properties

  • Sterile