Ostomy Accessories
by Suzhou Kangyouwei Medical Technology Co., Ltd. 37 variants
Ref Skin Barrier Film:80205Model ostomy powder：86005、86030、86050 skin barrier film：80010、80030、80060、80100、80230、80205 adhesive remover：81010、81030、81060、81100、81230、81205 skin barrier ring：83002、83003、83004 etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697525848OAccessories7N 06975258485081 | Date26 Nov 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ostomy Accessories
- Model / Reference
- ostomy powder：86005、86030、86050 skin barrier film：80010、80030、80060、80100、80230、80205 adhesive remover：81010、81030、81060、81100、81230、81205 skin barrier ring：83002、83003、83004 etc, Skin Barrier Film:80205
- Primary DI / UDI-DI
- 06975258485081
- Basic UDI-DI
- 697525848OAccessories7N
- EMDN Code
- A108004 Protective films / sprays for peristomal skin
- Device Class
- Class I
- EU 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
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