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SenSura Mio 18790

by Coloplast A/S

Ref 18790

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5708932123628191JR Basic UDI-DI 05701780406604UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780406604 UDI-DI Date17 Oct 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  • Withdrawn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

Trade Name
SenSura Mio
Generic Name
Multiple-piece urostomy bag, open-ended
Device Name
SenSura Mio uro bag adaptor
Model / Ref / Catalog
18790
Primary DI / UDI-DI
05701780406604 EUDAMED
05701780406543 GUDID
Basic UDI-DI
5708932123628191JR
Unit of Use DI
05701780406628
FDA Product Code
EXB
EMDN Code
A108099 Accessory devices for abdominal ostomy - other
GMDN Term
Multiple-piece urostomy bag, open-ended
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05701780406604
GUDID
05701780406543

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No