Two-piece Ostomy Bag and Baseplate
by Suzhou Kangyouwei Medical Technology Co., Ltd. China EUDAMED
Ref Two-piece Ostomy Bag:113436Model two-piece ostomy bag：113410、113411、113412、113421、113422、113431、113432、113433、113434、113435、113436。 214530、214531、214532、214541、214542、214551、214552、214561、214562、214563、214564、214565、214566、etc
EMDN A10020201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697525848Two-piece5M | Date26 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Two-piece Ostomy Bag and Baseplate
- Model / Reference
- two-piece ostomy bag：113410、113411、113412、113421、113422、113431、113432、113433、113434、113435、113436。 214530、214531、214532、214541、214542、214551、214552、214561、214562、214563、214564、214565、214566、etc, Two-piece Ostomy Bag:113436
- Primary DI / UDI-DI
- 06975258484107
- Basic UDI-DI
- 697525848Two-piece5M
- EMDN Code
- A10020201 Colostomy bags for two-part systems, 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
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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 61ce6911-2f80-412e-bb5c-11f99d7cf0c1