Sinogel
by IBSA FARMACEUTICI ITALIA srl 18 variants
Ref 8033638955765
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803363895IAK00269 08033638955765 | Date12 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sodium hyaluronate 2.4% and sodium chondroitin 1.6% - Visco-suppletive joint device
- Model / Reference
- 8033638955765
- Primary DI / UDI-DI
- 08033638955765
- Basic UDI-DI
- 803363895IAK00269
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Medical Purpose
- SINOGEL® with its particular formula and its high concentration of glycosaminoglycans (GAG) belongs to the latest generation of intra-articular treatments and is specifically designed for viscosupplementation of large joints for which a large volume of solution with a high concentration of hyaluronic acid without high viscosity is recommended. Thanks to a specific and patented treatment of the solution, the hyaluronic acid and sodium chondroitin chains present in the device interact with each other giving the solution rheological properties such as to obtain viscosity values lower than those of only hyaluronic acid at the same concentration.
Manufacturer details
- EUDAMED SRN
- IT-PR-000050852