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SenSura Mio Convex

by Coloplast A/S 574 variants

Ref 165100

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 23 Oct 2026. What this means

Overview

Meet the SenSura Mio Convex ostomy bag, a high-quality medical device designed for individuals with ostomies. With its unique convex design and adjustable closure system, it provides comfortable and secure placement for daily use. Our device is designed to meet the needs of patients requiring a reliable and durable solution.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322975088V Basic UDI-DI 05708932858434UDI-DIDate11 Mar 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  • Withdrawn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 Convex ostomy bag 1-piece closed
Model / Reference
165100
Primary DI / UDI-DI
05708932858434
Basic UDI-DI
57089322975088V
Unit of Use DI
05708932860437
EMDN Code
A1001010202 One-piece colostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Related devices

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

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No