Ankle support
by Yangzhou Sensport Healthcare Supplies Co., Ltd EUDAMED
Active
Ref BM-AN1097-LG-LModel BM-AK1099,BM-AN1097, BM-AP1098,BM-AK2302,BM-AK2301, BM-AK-2308,BM-AK2303,BM- AK2403,BM-AK2401，BM-AK2505
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697467894BM-AKQG | Date17 Sep 2026 | 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- Withdrawn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
- Ankle support
- Model / Reference
- BM-AK1099, BM-AN1097, BM-AP1098, BM-AK2302, BM-AK2301, BM-AK-2308, BM-AK2303, BM- AK2403, BM-AK2401，BM-AK2505, BM-AN1097-LG-L
- Primary DI / UDI-DI
- 06974678940170
- Basic UDI-DI
- 697467894BM-AKQG
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000057824
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Yangzhou Sensport Healthcare Supplies Co., Ltd
See all devices from Yangzhou Sensport Healthcare Supplies 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