Skip to content

SenSura Mio Convex

by Coloplast A/S 57 variants

Ref 19553

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322975088V Basic UDI-DI 05701780380171UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780380171 UDI-DI Date25 Apr 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
One-piece intestinal ostomy bag, closed-ended
Device Name
SenSura Mio Convex ostomy bag 1-piece closed
Model / Ref / Catalog
19553
Primary DI / UDI-DI
05701780380171 EUDAMED
05701780361545 GUDID
Basic UDI-DI
57089322975088V
Unit of Use DI
05701780380195
FDA Product Code
EXB
EMDN Code
A1001010202 One-piece colostomy bags for retracted stoma, convex, with tissue cover
GMDN Term
One-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780380171
GUDID
05701780361545

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

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No