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SenSura Mio Convex Flip 18928

by Coloplast A/S

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05701780367516 UDI-DI Date28 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SenSura Mio Convex Flip
Generic Name
One-piece intestinal ostomy bag, open-ended, single-use
Model / Ref / Catalog
18928
Primary DI / UDI-DI
05701780367516
FDA Product Code
EXB
GMDN Term
One-piece intestinal ostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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 (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No