One-piece Ostomy Bag
by Suzhou Kangyouwei Medical Technology Co., Ltd. China EUDAMED
Ref 5885Model 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 A1001010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697525848OstomyBagQE | Date25 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- 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, 5885
- Primary DI / UDI-DI
- 06975258483544
- Basic UDI-DI
- 697525848OstomyBagQE
- EMDN Code
- A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with 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
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 (1)
- EUDAMED 062511ac-8789-4711-bc7a-8a50d077b51b