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SenSura Mio

by Coloplast A/S 7 variants

Ref 115000

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 Number05701780420907 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  • Withdrawn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
115000
Primary DI / UDI-DI
05701780420907 EUDAMED
05708932679077 EUDAMED
05708932678339 EUDAMED
05708932109581 EUDAMED
05701780420938 EUDAMED
05701780420822 EUDAMED
05701780421058 GUDID
Basic UDI-DI
57089322975679D
Unit of Use DI
05701780420921, 05701780071192, 05701780071284, 05708932109574, 05701780420952, 05701780420846
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
Liechtenstein
Norway
France
Poland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 60 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780420907
05708932679077
05708932678339
05708932109581
05701780420938
05701780420822
GUDID
05701780421058

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