Lower Limb Brace
by Shijiazhuang aofeite imp&exp co., ltd 14 variants
Ref H031Model H016,H025,H026,H027,H028,H029,H030,H031,H032,H033,H034,H035,H036,H037,H038,H039,H040,H041,H042,H043,H044,H045,H046,H047,H048, H050,H052,H053,H054,H055,H056,H057,H058,H059,H060,H061,H062,H064,H065,H069
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 | Number697852731ULBXF 06953751901130 | Date21 Apr 2026 | 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- Withdrawn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
- H016, H025, H026, H027, H028, H029, H030, H031, H032, H033, H034, H035, H036, H037, H038, H039, H040, H041, H042, H043, H044, H045, H046, H047, H048, H050, H052, H053, H054, H055, H056, H057, H058, H059, H060, H061, H062, H064, H065, H069
- Primary DI / UDI-DI
- 06953751901130
- Basic UDI-DI
- 697852731ULBXF
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- EU market of registration
- Lithuania
Manufacturer details
- EUDAMED SRN
- CN-MF-000011825
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shijiazhuang aofeite imp&exp co., ltd
See all devices from Shijiazhuang aofeite imp&exp 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