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Sinovial 50

by Ibsa Farmaceutici Italia SRL 2 variants

Ref 8033638957196

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.22/4839.4 Date18 Sep 2026IssuedStatusExpiring expires 6 Jun 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.22/4839.4 Expiring Reissued Expires in 217 days

    Technical documentation EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    18 Sep 2026
    Expires
    6 Jun 2027
  • EPT 0477.MDR.22/4840.3 Expiring Reissued Expires in 217 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    1 Oct 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  • Withdrawn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
Visco-Suppletive Joint Device
Model / Reference
8033638957196
Primary DI / UDI-DI
08033638957196
Basic UDI-DI
803363895IA0034V
Direct Marketing DI
08033638957196
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008111

Other devices from IBSA Farmaceutici Italia Srl

See all devices from IBSA Farmaceutici Italia Srl →

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