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SenSura Mio Convex

by Coloplast A/S 57 variants

Ref 168050

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322975689F Basic UDI-DI Date17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932857178 UDI-DI Date30 Apr 2026ListedStatusListed 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  • Withdrawn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 urostomy bag, open-ended, single-use
Device Name
SenSura Mio Convex urostomy bag 1-piece
Model / Ref / Catalog
168050
Primary DI / UDI-DI
05708932857178 EUDAMED
05708932848053 EUDAMED
05708932076760 EUDAMED
05701780438186 EUDAMED
05701780438216 EUDAMED
05701780438384 GUDID
Basic UDI-DI
57089322975689F
Unit of Use DI
05708932859172, 05701780135900, 05708932076753, 05701780438209, 05701780438230
FDA Product Code
EXB
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
GMDN Term
One-piece urostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Sweden
Poland
Austria
Liechtenstein
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932857178
05708932848053
05708932076760
05701780438186
05701780438216
GUDID
05701780438384

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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