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One-piece Ostomy Bag

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

Ref One-piece Ostomy Bag:311001, 214072, 311003, 214067, 113091, 311001, 18722, 214518, 214082, 214083, 214064, 18721, 15251, 214084, 113040, 214061, 214081, 214092, 113043, 113052, 214073, 321003, 113075, 5585, 214049, 15570, 18723, 214093, 321001, 113071, 214074, 113085, 214517Model 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 A1001010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697525848OstomyBagQE Basic UDI-DIDate26 Nov 2025RegisteredStatusActive

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  • Withdrawn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 22 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, One-piece Ostomy Bag:311001, 214072, 311003, 214067, 113091, 311001, 18722, 214518, 214082, 214083, 214064, 18721, 15251, 214084, 113040, 214061, 214081, 214092, 113043, 113052, 214073, 321003, 113075, 5585, 214049, 15570, 18723, 214093, 321001, 113071, 214074, 113085, 214517
Primary DI / UDI-DI
06975258480000, 06975258483414, 06975258483018, 06975258483384, 06975258483209, 06975258483001, 06975258483605, 06975258483315, 06975258483452, 06975258483469, 06975258483353, 06975258483629, 06975258483568, 06975258483476, 06975258483025, 06975258483322, 06975258483445, 06975258483490, 06975258483063, 06975258483070, 06975258483421, 06975258483223, 06975258483124, 06975258483186, 06975258483261, 06975258483575, 06975258483612, 06975258483506, 06975258483216, 06975258483094, 06975258483438, 06975258483162, 06975258483308
Basic UDI-DI
697525848OstomyBagQE
EMDN Code
A1001010101, A1001010202, A1001030102, A1001030101, A1001010102, A1001010201, A1001030201
Device Class
Class I
Market of Registration
Austria

Manufacturer details

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

Other devices from Suzhou Kangyouwei Medical Technology Co., Ltd.

See all devices from Suzhou Kangyouwei 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 (33)

  • EUDAMED c0deabc0-187c-4b4d-8d85-fbc5749b9d7b 61 fields · synced 22 Oct 2026
  • EUDAMED 06975258483414|697525848OSTOMYBAGQE 61 fields · synced 18 Jun 2026
  • EUDAMED 06975258483018|697525848OSTOMYBAGQE 61 fields · synced 9 Jul 2026
  • EUDAMED 06975258483384|697525848OSTOMYBAGQE 61 fields · synced 9 Jul 2026
  • EUDAMED 06975258483209|697525848OSTOMYBAGQE 61 fields · synced 10 Jul 2026
  • EUDAMED 06975258483001|697525848OSTOMYBAGQE 61 fields · synced 11 Jul 2026
  • EUDAMED 06975258483605|697525848OSTOMYBAGQE 61 fields · synced 11 Jul 2026
  • EUDAMED 06975258483315|697525848OSTOMYBAGQE 61 fields · synced 11 Jul 2026
  • EUDAMED 06975258483452|697525848OSTOMYBAGQE 61 fields · synced 13 Jul 2026
  • EUDAMED 06975258483469|697525848OSTOMYBAGQE 61 fields · synced 14 Jul 2026
  • EUDAMED 06975258483353|697525848OSTOMYBAGQE 61 fields · synced 14 Jul 2026
  • EUDAMED 06975258483629|697525848OSTOMYBAGQE 61 fields · synced 15 Jul 2026
  • EUDAMED 06975258483568|697525848OSTOMYBAGQE 61 fields · synced 16 Jul 2026
  • EUDAMED 06975258483476|697525848OSTOMYBAGQE 61 fields · synced 19 Jul 2026
  • EUDAMED 06975258483025|697525848OSTOMYBAGQE 61 fields · synced 20 Jul 2026
  • EUDAMED 06975258483322|697525848OSTOMYBAGQE 61 fields · synced 20 Jul 2026
  • EUDAMED 06975258483445|697525848OSTOMYBAGQE 61 fields · synced 21 Jul 2026
  • EUDAMED 06975258483490|697525848OSTOMYBAGQE 61 fields · synced 21 Jul 2026
  • EUDAMED 06975258483063|697525848OSTOMYBAGQE 61 fields · synced 23 Jul 2026
  • EUDAMED 06975258483070|697525848OSTOMYBAGQE 61 fields · synced 24 Jul 2026
  • EUDAMED 06975258483421|697525848OSTOMYBAGQE 61 fields · synced 26 Jul 2026
  • EUDAMED 06975258483223|697525848OSTOMYBAGQE 61 fields · synced 26 Jul 2026
  • EUDAMED 06975258483124|697525848OSTOMYBAGQE 61 fields · synced 26 Jul 2026
  • EUDAMED 06975258483186|697525848OSTOMYBAGQE 61 fields · synced 29 Jul 2026
  • EUDAMED 06975258483261|697525848OSTOMYBAGQE 61 fields · synced 30 Jul 2026
  • EUDAMED 06975258483575|697525848OSTOMYBAGQE 61 fields · synced 31 Jul 2026
  • EUDAMED 06975258483612|697525848OSTOMYBAGQE 61 fields · synced 31 Jul 2026
  • EUDAMED 06975258483506|697525848OSTOMYBAGQE 61 fields · synced 31 Jul 2026
  • EUDAMED 06975258483216|697525848OSTOMYBAGQE 61 fields · synced 1 Aug 2026
  • EUDAMED 06975258483094|697525848OSTOMYBAGQE 61 fields · synced 3 Aug 2026
  • EUDAMED 06975258483438|697525848OSTOMYBAGQE 61 fields · synced 4 Aug 2026
  • EUDAMED 06975258483162|697525848OSTOMYBAGQE 61 fields · synced 4 Aug 2026
  • EUDAMED 06975258483308|697525848OSTOMYBAGQE 61 fields · synced 4 Aug 2026