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cofoe

by Cofoe Medical Technology Co., Ltd 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06950715505588 UDI-DI Date9 Dec 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
One-piece intestinal ostomy bag, open-ended, single-use
Model / Reference
One-piece Drainable IIeostomy Bag (4010V)
Primary DI / UDI-DI
06950715505588
FDA Product Code
EZQ
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

Related devices

Category: One-piece intestinal ostomy bag, open-ended

Other devices from Cofoe Medical Technology Co., Ltd.

See all devices from Cofoe Medical Technology Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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