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SenSura Mio Convex

by Coloplast A/S 57 variants

Ref 18544

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322975969L Basic UDI-DI Date22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05701780389792 UDI-DI Date8 Jun 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  • Withdrawn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
Intestinal ostomy base plate, convex
Device Name
SenSura Mio Convex flex ostomy baseplate
Model / Ref / Catalog
18544
Primary DI / UDI-DI
05701780389792 EUDAMED
05701780386371 EUDAMED
05701780386920 EUDAMED
05708932770590 EUDAMED
05701780390651 EUDAMED
05701780385503 GUDID
Basic UDI-DI
57089322975969L
Unit of Use DI
05701780389815, 05701780386395, 05701780386944, 05708932770576, 05701780390675
FDA Product Code
EXB
EMDN Code
A1002010402 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with introflex stoma
GMDN Term
Intestinal ostomy base plate, convex
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Germany
Netherlands
Norway
Denmark
Finland
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
05701780389792
05701780386371
05701780386920
05708932770590
05701780390651
GUDID
05701780385503

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