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Sinogel

by Ibsa Farmaceutici Italia SRL 18 variants

Ref 8033638958100

Expiring European Union

CE MDR

Valid until

6 Jun 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803363895IA0024T Basic UDI-DI 08033638958100UDI-DIDate2 Dec 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.22/4843.2 Expiring Reissued Expires in 213 days

    Technical documentation EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    11 Mar 2025
    Expires
    6 Jun 2027
  • EPT 0477.MDR.22/4844.2 Expiring Reissued Expires in 213 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    11 Mar 2025
    Expires
    6 Jun 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
SODIUM HYALURONATE 2.4% and SODIUM CHONDROITIN 1.6% - VISCO-SUPPLETIVE JOINT DEVICE
Model / Reference
8033638958100
Primary DI / UDI-DI
08033638958100
Basic UDI-DI
803363895IA0024T, 803363895IAK00269
Direct Marketing DI
08033638958100
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
France
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-MF-000008111

Other devices from IBSA Farmaceutici Italia Srl

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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