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- Withdrawn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
- 04058509370809, 04058509489990, 04058509370847, 04058509489914, 04058509489778, 04058509489877, 04058509489808, 04058509489822, 04058509370830, 04058509490019, 04058509490057, 04058509370878, 04058509370496, 04058509370601, 04058509370717, 04058509370564, 04058509370489, 04058509370502, 04058509489853, 04058509489815, 04058509370618, 04058509489761, 04058509370519
- Basic UDI-DI
- 4009706Y06309901ZN
- Direct Marketing DI
- 0405850937080904058509489990040585093708470405850948991404058509489778040585094898770405850948980804058509489822040585093708300405850949001904058509490057040585093708780405850937049604058509370601040585093707170405850937056404058509370489040585093705020405850948985304058509489815040585093706180405850948976104058509370519
- 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