Avalon K2 28R External Foot Prosthesis
by Blatchford Products Limited
Ref AV28RModel AvalonK2
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 | Number5050649AVALONK2Y4 05050649025433 | Date2 Oct 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- Withdrawn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
- AvalonK2
- Model / Reference
- AvalonK2, AV28R
- Primary DI / UDI-DI
- 05050649025433
- Basic UDI-DI
- 5050649AVALONK2Y4
- EMDN Code
- Y062403 Foot partial prostheses (including toe prostheses)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- UK-MF-000048777
- Authorised representative
- Blatchford Europe GmbH DE-AR-000006292
Other devices from Blatchford Products Limited
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