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Levantra

by Gruppo Farmaimpresa SRL Italy EUDAMED

Ref FT.MDR.74.27.3Model Acido ialuronico sale sodico 2% per iniezione intra-articolare

EMDN P900402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805574884FTMDR74YE Basic UDI-DIDate24 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

3 certificates · EUDAMED

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

    Technical documentation EU MDR

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

    Quality management system EU MDR

    Notified body
    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  • 020-00-04-MDR Withdrawn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

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

Specification

EUDAMED · synced 25 Oct 2026

Device Name
ARTOX 2% (1 siringa preriempita)
Model / Reference
Acido ialuronico sale sodico 2% per iniezione intra-articolare, FT.MDR.74.27.3
Primary DI / UDI-DI
08055748845217
Basic UDI-DI
805574884FTMDR74YE
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08055748845217|805574884FTMDR74YE 61 fields · synced 25 Oct 2026