Robina
by Anita Dr. Helbig GmbH 3 variants
Ref 5792X
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 | Number4009706Y06309901ZN | Date15 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- Withdrawn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
- Accessories
- Model / Reference
- 5792X
- Primary DI / UDI-DI
- 04058509247149, 04058509247040, 04058509247057, 04058509247187, 04058509246807, 04058509246784, 04058509246845, 04058509246821, 04058509247088, 04058509247033, 04058509247200, 04058509246913, 04058509246968, 04058509247170, 04058509247163, 04058509247064, 04058509247231, 04058509246869, 04058509246944, 04058509246852, 04058509246883, 04058509247095, 04058509247071, 04058509247316, 04058509246982, 04058509247194, 04058509247248, 04058509247101, 04058509246814, 04058509247255, 04058509247279, 04058509246920, 04058509247019, 04058509246906, 04058509247125, 04058509247156, 04058509247002, 04058509247309, 04058509246951, 04058509246876, 04058509246937, 04058509247217, 04058509246975, 04058509247026, 04058509246838, 04058509247224, 04058509247286, 04058509246791, 04058509247293
- Basic UDI-DI
- 4009706Y06309901ZN
- Direct Marketing DI
- 04058509247149040585092470400405850924705704058509247187040585092468070405850924678404058509246845040585092468210405850924708804058509247033040585092472000405850924691304058509246968040585092471700405850924716304058509247064040585092472310405850924686904058509246944040585092468520405850924688304058509247095040585092470710405850924731604058509246982040585092471940405850924724804058509247101040585092468140405850924725504058509247279040585092469200405850924701904058509246906040585092471250405850924715604058509247002040585092473090405850924695104058509246876040585092469370405850924721704058509246975040585092470260405850924683804058509247224040585092472860405850924679104058509247293
- EMDN Code
- Y063099 Non-extremity prostheses - other
- Device Class
- Class I
- EU 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