Lower limb brace
by Shijiazhuang aofeite imp&exp co., ltd 14 variants
Ref AFT0105Model Ankle brace BP-H081-01 BP-H081-02 BP-H081-03 BP-H081-04 Ankle brace HH235-1 Ankle brace AFT0104 knee brace BP-H044-01 BP-H044-02 BP-H044-03 BP-H044-04 BP-H044-05 Knee brace A084 etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
A comprehensive Lower limb brace designed for optimal support and recovery, utilizing advanced materials and cutting-edge technology to provide superior comfort and performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697852731LLB01N5 06978527310428 | Date16 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- Withdrawn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
- Model / Reference
- Ankle brace BP-H081-01 BP-H081-02 BP-H081-03 BP-H081-04 Ankle brace HH235-1 Ankle brace AFT0104 knee brace BP-H044-01 BP-H044-02 BP-H044-03 BP-H044-04 BP-H044-05 Knee brace A084 etc, AFT0105
- Primary DI / UDI-DI
- 06978527310428
- Basic UDI-DI
- 697852731LLB01N5
- EMDN Code
- Y06121201 Passive knee-ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011825
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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