FA197 Conforming Bandage 5cm X 4M
by Suzhou Sunmed Co., Ltd. EUDAMED
Active
Ref FA197
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697386485DMBANNONKV | Date25 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Bandage
- Model / Reference
- FA197
- Primary DI / UDI-DI
- 06973864854208
- Basic UDI-DI
- 697386485DMBANNONKV
- Direct Marketing DI
- 06973864854208
- EMDN Code
- M03030199 Elastic fixing bandages - other
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000010170
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Suzhou Sunmed 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