Posterior Leaf Spring AFO
by Regal Prosthesis Limited 8 variants
Ref 5-01-AFO001-L-S
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 | Number48952003005RT7F 04895200314387 | Date29 Jun 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- Withdrawn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
- Orthotics and Rehabilitation
- Model / Reference
- 5-01-AFO001-L-S
- Primary DI / UDI-DI
- 04895200314387
- Basic UDI-DI
- 48952003005RT7F
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- HK-MF-000028642
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Regal Prosthesis 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