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Ostomy Bag and Accessories

by Cofoe Medical Technology Co., Ltd. China EUDAMEDGUDID

Ref One-piece Drainable IIeostomy BagModel One-piece Drainable IIeostomy Bag, One-piece Urostomy Bag, Two-piece Closed Colostomy Bag, Two-piece Drainable IIeostomy Bag, Skin Barrier Wipe, Adhesive Remover, Skin Barrier Paste, Ostomy Belt, Barrier Ring, Barrier Strip Product code EZQEMDN A1001020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06950715504482 UDI-DIDate9 Dec 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number69507155OBEF Basic UDI-DIDate27 Sep 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
Ostomy Bag and Accessories EUDAMED
cofoe GUDID
Generic Name
One-piece intestinal ostomy bag, open-ended, single-use
Model / Reference
One-piece Drainable IIeostomy Bag EUDAMED
One-piece Urostomy Bag EUDAMED
Two-piece Closed Colostomy Bag EUDAMED
Two-piece Drainable IIeostomy Bag EUDAMED
Skin Barrier Wipe EUDAMED
Adhesive Remover EUDAMED
Skin Barrier Paste EUDAMED
Ostomy Belt EUDAMED
Barrier Ring EUDAMED
Barrier Strip EUDAMED
One-piece Drainable IIeostomy Bag(4005C) GUDID
Primary DI / UDI-DI
06950715504482
Basic UDI-DI
69507155OBEF
Direct Marketing DI
06950715504482
FDA Product Code
EZQ
EMDN Code
A1001020101 One-piece ileostomy bags for non-retracted stoma, flat, w/o tissue cover
GMDN Term
One-piece intestinal ostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
Market of Registration
Northern Ireland
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000001077
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Cofoe Medical Technology Co., Ltd.

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

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 841e2954-72de-4b0a-b1da-78f42fc7aab1 61 fields · synced 25 Oct 2026
  • FDA UDI d6fe7b95-864d-4497-97a5-f59956077b58 33 fields · synced 30 May 2026