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Ostomy Accessories

by Suzhou Kangyouwei Medical Technology Co., Ltd. China EUDAMED

Ref Skin Barrier Film:80230Model ostomy powder：86005、86030、86050 skin barrier film：80010、80030、80060、80100、80230、80205 adhesive remover：81010、81030、81060、81100、81230、81205 skin barrier ring：83002、83003、83004 etc

EMDN A108004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697525848OAccessories7N Basic UDI-DIDate26 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ostomy Accessories
Model / Reference
ostomy powder：86005、86030、86050 skin barrier film：80010、80030、80060、80100、80230、80205 adhesive remover：81010、81030、81060、81100、81230、81205 skin barrier ring：83002、83003、83004 etc, Skin Barrier Film:80230
Primary DI / UDI-DI
06975258485074
Basic UDI-DI
697525848OAccessories7N
EMDN Code
A108004 Protective films / sprays for peristomal skin
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050548
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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 7a6409af-a925-4512-98eb-e285a76095fe 61 fields · synced 24 Oct 2026