Lower limb brace
by Xingtai Huaqi Medical Equipment Co., Ltd 18 variants
Ref OA Knee Joint Orthosis(Left)Model Ankle-Foot Orthosis: Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version (Size S, Left; Size S, Right; Size M, Left; Size M, Right; Size L, Left; Size L, Right)
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 | Number697060448XTHQ00128 06970604480420 | Date23 Apr 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- Withdrawn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
- Lower limb brace
- Model / Reference
- Ankle-Foot Orthosis: Adjustable Ankle-Foot Fixation Orthosis Type III, Short Version (Size S, Left, Size S, Right, Size M, Size L, Right), OA Knee Joint Orthosis(Left)
- Primary DI / UDI-DI
- 06970604480420
- Basic UDI-DI
- 697060448XTHQ00128
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047104
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xingtai Huaqi Medical Equipment Co., Ltd
See all devices from Xingtai Huaqi Medical Equipment 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