Lower limb orthosis
by Xiamen Dorrella Health Technology Co., Ltd China EUDAMED
Ref KS9001Model KS9001、KS9002、KS9003、KS9004、KS9005、KS9006、KS9007、 KS9008、KS9009、KS9010、KS9011、KS9012、KS9013、KS9014、KS9015
EMDN Y061203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697678522LLOK01XG | Date11 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lower limb orthosis
- Model / Reference
- KS9001、KS9002、KS9003、KS9004、KS9005、KS9006、KS9007、 KS9008、KS9009、KS9010、KS9011、KS9012、KS9013、KS9014、KS9015, KS9001
- Primary DI / UDI-DI
- 06976785221005, 06976785224631
- Basic UDI-DI
- 697678522LLOK01XG
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- Market of Registration
- AustriaHungary
Manufacturer details
- EUDAMED SRN
- CN-MF-000036851
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Xiamen Dorrella Health Technology Co., Ltd
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 (2)
- EUDAMED e44696d4-d04d-47e3-9198-015fca17c9ca
- EUDAMED 06976785224631|697678522LLOK01XG