Versailles
by Anita Dr. Helbig GmbH 48 variants
Ref 5777X
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- Withdrawn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
- 5777X
- Primary DI / UDI-DI
- 04009706971405, 04009706362432, 04009706971689, 04009706971504, 04009706362500, 04009706390923, 04009706362579, 04009706391036, 04009706391135, 04009706362517, 04009706391074, 04009706391029, 04009706391104, 04009706971511, 04009706199502, 04009706971580, 04009706194538, 04009706362333, 04009706199519, 04009706971733, 04009706194552, 04009706362487, 04009706971634, 04009706391005, 04009706194460, 04009706971672, 04009706199496, 04009706971757, 04009706194453, 04009706194385, 04009706391111, 04009706199489, 04009706194507, 04009706362388, 04009706194422, 04009706391012, 04009706199427, 04009706971566, 04009706362531, 04009706362456, 04009706362357, 04009706971665, 04009706390961, 04009706362524, 04009706971382, 04009706971528, 04009706362463, 04009706971726, 04009706390992, 04009706194545
- Basic UDI-DI
- 4009706Y06309901ZN
- Direct Marketing DI
- 0400970697140504009706362432040097069716890400970697150404009706362500040097063909230400970636257904009706391036040097063911350400970636251704009706391074040097063910290400970639110404009706971511040097061995020400970697158004009706194538040097063623330400970619951904009706971733040097061945520400970636248704009706971634040097063910050400970619446004009706971672040097061994960400970697175704009706194453040097061943850400970639111104009706199489040097061945070400970636238804009706194422040097063910120400970619942704009706971566040097063625310400970636245604009706362357040097069716650400970639096104009706362524040097069713820400970697152804009706362463040097069717260400970639099204009706194545
- 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