Skip to content

One-piece Ostomy Bag

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

Ref 113042Model 311001、311003、113040、113041、113051、113042、113043、113052、113053、113071、113072、113073、113075、113076、113081、113082、113085、113086、5585、11084、113091。 321001、321003、214046、214047、214048、etc

EMDN A1001030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697525848OstomyBagQE Basic UDI-DIDate25 May 2026RegisteredStatusActive

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
One-piece Ostomy Bag
Model / Reference
311001、311003、113040、113041、113051、113042、113043、113052、113053、113071、113072、113073、113075、113076、113081、113082、113085、113086、5585、11084、113091。 321001、321003、214046、214047、214048、etc, 113042
Primary DI / UDI-DI
06975258483056
Basic UDI-DI
697525848OstomyBagQE
EMDN Code
A1001030101 One-piece urostomy bags for non-retracted stoma, flat, w/o tissue cover
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 a77c3ed6-14ea-4b53-a87d-919c54d4cb0e 61 fields · synced 24 Oct 2026