Lower Limbs brace
by Cangzhou Xiankang Medical Equipment Co., Ltd China EUDAMED
Ref PD-401Model PD-401,PD-401(1),PD-402,PD-403,PD-403(1),PD-404,PD-404(1),PD-405,PD-406,PD-407,PD-408,PD-408(1),PD-409,PD-410,PD-513,PD-514,PD-515,PD-516,PD-517,PD-518,PD-519,PD-520,PD-521,PD-522,PD-523,PD-524,PD-525,PD-526,PD-526(1),PD-527, etc
EMDN Y061203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697679580XKLL2L | Date10 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lower Limbs brace
- Model / Reference
- PD-401, PD-401(1), PD-402, PD-403, PD-403(1), PD-404, PD-404(1), PD-405, PD-406, PD-407, PD-408, PD-408(1), PD-409, PD-410, PD-513, PD-514, PD-515, PD-516, PD-517, PD-518, PD-519, PD-520, PD-521, PD-522, PD-523, PD-524, PD-525, PD-526, PD-526(1), PD-527, etc
- Primary DI / UDI-DI
- 06976795800498
- Basic UDI-DI
- 697679580XKLL2L
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044648
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cangzhou Xiankang Medical Equipment Co., Ltd
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 7cf049b9-0752-42da-99eb-b9c839ee6e65