Dynamic Ankle-Foot Orthosis
by Wenzhou Kunbu Robotics Technology Co., Ltd. 12 variants
Ref QBW-ANK-CLModel QBW-ANK-AS, QBW-ANK-BS, QBW-ANK-CS, QBW-ANK-DS, QBW-ANK-AM, QBW-ANK-BM, QBW-ANK-CM, QBW-ANK-DM, QBW-ANK-AL, QBW-ANK-BL, QBW-ANK-CL, QBW-ANK-DL
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 | Number697939444QBW2B 06979394440027 | Date4 Sep 2026 | 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- Withdrawn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
- Model / Reference
- QBW-ANK-AS, QBW-ANK-BS, QBW-ANK-CS, QBW-ANK-DS, QBW-ANK-AM, QBW-ANK-BM, QBW-ANK-CM, QBW-ANK-DM, QBW-ANK-AL, QBW-ANK-BL, QBW-ANK-CL, QBW-ANK-DL
- Primary DI / UDI-DI
- 06979394440027
- Basic UDI-DI
- 697939444QBW2B
- Direct Marketing DI
- 06979394440027
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000058325
- Authorised representative
- HUMISS TRADING S. L. ES-AR-000040177
Other devices from Wenzhou Kunbu Robotics Technology Co., Ltd.
See all devices from Wenzhou Kunbu Robotics 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