3Dynamic AFO Kit 100 LH / Left / Large-Extra large
Ref 3DAFO Kit/100LH/LT/L-XLModel 3DYNAMIC AFO KIT STEP-ON 100/LH
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 | Number5200413201994LB 05200413201994 | Date6 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- Withdrawn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
- Model / Reference
- 3DYNAMIC AFO KIT STEP-ON 100/LH, 3DAFO Kit/100LH/LT/L-XL
- Primary DI / UDI-DI
- 05200413201994
- Basic UDI-DI
- 5200413201994LB
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- GR-MF-000013450
Other devices from Μ.birli - a.tsitouras O.E.
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