Ostomy bag
by Zhejiang Ailebao Medical Technology CO., LTD. China EUDAMED
Ref Type5010SeriesModel Type5010Series/5013Series/5015Series Type5020Series/5023Series/5025Series Type5030Series Type5040Series Type5050Series/5053Series/5055Series Type5060Series/5063Series/5065Series Type5070Series
EMDN A1001010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697521811type501BP | Date31 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ostomy bag
- Model / Reference
- Type5010Series/5013Series/5015Series Type5020Series/5023Series/5025Series Type5030Series Type5040Series Type5050Series/5053Series/5055Series Type5060Series/5063Series/5065Series Type5070Series, Type5010Series
- Primary DI / UDI-DI
- 06975218118011
- Basic UDI-DI
- 697521811type501BP
- EMDN Code
- A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027699
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Ailebao 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 3286c17c-b9de-4b4f-9043-0f6ac328c3fa