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SenSura Mio

by Coloplast A/S 7 variants

Ref 114970

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 Number57089322975679D Basic UDI-DI Date29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932905343 UDI-DI Date21 Jan 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  • Withdrawn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
Multiple-piece urostomy bag, open-ended
Device Name
SenSura Mio click urostomy bag 2-piece
Model / Ref / Catalog
114970
Primary DI / UDI-DI
05708932905343 EUDAMED
05708932922876 EUDAMED
05701780417822 EUDAMED
05708932911894 EUDAMED
05701780417938 EUDAMED
05701780163125 EUDAMED
05701780417907 EUDAMED
05701780418256 GUDID
Basic UDI-DI
57089322975679D
Unit of Use DI
05708932904667, 05701780070690, 05701780417891, 05701780070669, 05701780417952, 05701780070638, 05701780417921
FDA Product Code
EXB
EMDN Code
A10020402 Urostomy bags for two-part systems, with tissue cover
GMDN Term
Multiple-piece urostomy bag, open-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Poland
France
Austria
Sweden
Liechtenstein
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 50 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932905343
05708932922876
05701780417822
05708932911894
05701780417938
05701780163125
05701780417907
GUDID
05701780418256

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