Silicone Liner for Below Knee Amputee Without Lock Size 28
by Roadrunnerfoot Engineering srl
Ref 3.006.01.BK.28Model SIZE 16,20,24,26,28,32,38,44 TYPE WITHOUT LOCK AND WITH MATRIX AND LOCK
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 | Number8055748723.006.01.BKR6 08055748727285 | Date6 Jul 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- Withdrawn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
- Device Name
- Silicone Liner for Below Knee Amputee
- Model / Reference
- SIZE 16, 20, 24, 26, 28, 32, 38, 44 TYPE WITHOUT LOCK AND WITH MATRIX AND LOCK, 3.006.01.BK.28
- Primary DI / UDI-DI
- 08055748727285
- Basic UDI-DI
- 8055748723.006.01.BKR6
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000008242
Other devices from Roadrunnerfoot Engineering srl
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