Ankle Brace
by Burman Enterprise EUDAMED
Active
Ref B09LV69LFJ, B09LLPDTYV, B09NXNXVX8, B0C3LLBGM2, B09LV4M578Model B09LLMP3XL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number819504020717CR | Date23 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Ankle Brace
- Model / Reference
- B09LLMP3XL, B09LV69LFJ, B09LLPDTYV, B09NXNXVX8, B0C3LLBGM2, B09LV4M578
- Primary DI / UDI-DI
- 00819504020755, 00819504020731, 00819504020786, 00819504020908, 00819504020779
- Basic UDI-DI
- 819504020717CR
- EMDN Code
- Y061218 Hip-knee-ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- SE-MF-000048669
Other devices from Burman Enterprise
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