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Jesitrox 2% (1 siringa preriempita)

by Gruppo Farmaimpresa SRL

Ref FT.MDR.74Model Acido ialuronico sale sodico 2% per iniezione intra-articolare

Active European Union

CE MDR

Valid until

9 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

3 certificates

Certifier ITALCERT SRL

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 Number009-00-21-MDR Date6 Oct 2026IssuedStatusActive expires 9 Jan 2028

Certificates

3 certificates · EUDAMED

EUDAMED certificates (3)
  • 021-00-06-MDR Active Supplemented

    Technical documentation EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    29 Jul 2026
    Expires
    21 Jun 2028
    Reason
    Add device or group
  • 009-00-21-MDR Active Supplemented

    Quality management system EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    6 Oct 2026
    Expires
    9 Jan 2028
    Reason
    Add device or group
  • 020-00-04-MDR Withdrawn

    Quality management system EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    9 Jun 2025
    Expires
    21 Jun 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ARTOX 2% (1 siringa preriempita)
Model / Reference
Acido ialuronico sale sodico 2% per iniezione intra-articolare, FT.MDR.74
Primary DI / UDI-DI
08055748843657
Basic UDI-DI
805574884FTMDR74YE
EMDN Code
A02010799 Prefilled syringes - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000012625

Other devices from Gruppo Farmaimpresa SRL

See all devices from Gruppo Farmaimpresa 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