Skip to content

Sinogel

by IBSA FARMACEUTICI ITALIA srl 18 variants

Ref 8033638955765

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363895IAK00269 Basic UDI-DI 08033638955765UDI-DIDate12 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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

Other devices from IBSA Farmaceutici Italia Srl

See all devices from IBSA Farmaceutici Italia Srl →

Properties

  • Sterile