Sophia
by Anita Dr. Helbig GmbH EUDAMED
Active
Ref 4709X
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4009706Y06309901ZN | Date15 Jun 2026 | 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- Withdrawn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
- Accessories
- Model / Reference
- 4709X
- Primary DI / UDI-DI
- 04058509489716, 04058509489662, 04058509489952, 04058509370700, 04058509370632, 04058509489785, 04058509489631, 04058509370670, 04058509370885, 04058509370793, 04058509490040, 04058509370571, 04058509370595, 04058509489792, 04058509489884, 04058509370755, 04058509370588, 04058509489679, 04058509370823, 04058509370663, 04058509370731, 04058509489709, 04058509370649, 04058509489723, 04058509370908, 04058509370694, 04058509370892, 04058509489587, 04058509370526, 04058509370915, 04058509370540, 04058509489839, 04058509370465, 04058509370854, 04058509489891, 04058509489969, 04058509489846, 04058509370472, 04058509370762, 04058509489655, 04058509490033, 04058509370861, 04058509489754, 04058509370786, 04058509370748, 04058509370779, 04058509370533, 04058509370687, 04058509489938, 04058509489747
- Basic UDI-DI
- 4009706Y06309901ZN
- Direct Marketing DI
- 0405850948971604058509489662040585094899520405850937070004058509370632040585094897850405850948963104058509370670040585093708850405850937079304058509490040040585093705710405850937059504058509489792040585094898840405850937075504058509370588040585094896790405850937082304058509370663040585093707310405850948970904058509370649040585094897230405850937090804058509370694040585093708920405850948958704058509370526040585093709150405850937054004058509489839040585093704650405850937085404058509489891040585094899690405850948984604058509370472040585093707620405850948965504058509490033040585093708610405850948975404058509370786040585093707480405850937077904058509370533040585093706870405850948993804058509489747
- EMDN Code
- Y063099 Non-extremity prostheses - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- DE-MF-000012631
Other devices from Anita Dr. Helbig GmbH
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