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Ostomy Bag and Accessories

by Cofoe Medical Technology Co., Ltd. China EUDAMED

Ref Skin Barrier Wipe 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 A108004

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

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
Primary DI / UDI-DI
06950715506967
Basic UDI-DI
69507155OBEF
EMDN Code
A108004 Protective films / sprays for peristomal skin
Device Class
Class I
Market of Registration
Spain

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 323dcdce-3037-4797-9109-08bd0782249d 61 fields · synced 22 Oct 2026