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Ostomy Bag and Accessorie

by Cofoe Medical Technology Co., Ltd. China EUDAMED

Ref One-piece Urostomy Bag10pcs，Skin Barrier Wipe(1 box, 20 pcs/box) + Adhesive Remover20 pcs&1box，Barrier Strip 20pcs&1box)Model 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 EMDN A1001020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69507155OBEF Basic UDI-DIDate27 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Ostomy Bag and Accessories
Model / Reference
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, One-piece Urostomy Bag10pcs，Skin Barrier Wipe(1 box, 20 pcs/box) + Adhesive Remover20 pcs&1box，Barrier Strip 20pcs&1box)
Primary DI / UDI-DI
06950715574393
Basic UDI-DI
69507155OBEF
EMDN Code
A1001020101 One-piece ileostomy bags for non-retracted stoma, flat, w/o tissue cover
Device Class
Class I
Market of Registration
Germany

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
Other properties (13)
  • 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

Sources (1)

  • EUDAMED adfe3975-ed10-4971-a4f6-7723c59f62f6-1 61 fields · synced 23 Oct 2026