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Garze Laparotomiche Non Sterili

by Santex S.p.A. EUDAMED

Active European Union

Ref FR3D0560X4INNBL, FR3D3030X4INABL, FR3D2020S4INN, FR3D4545X4IVABL, FR5D4040X4INA, FR3D4040S4INNBL, FR3D4570X4INNBL, FR3D2525X4INNBL, FR5D4570X4INABL, FR3D4545X4INABL, FR3D4570X4IVABL, FR3D2020X4INNBL, FR3D1060X4INABL, FR5D4545X4IXABL, FR5D3030F4SNA, FR3D0530X4INNBL, FR3D4570X4INABL, FR5D2525X4INAModel FALDELLE NON STERILI/STERILIZZABILI

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8011809GAR6LAPNS2L Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00155-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    18 Jun 2025
    Expires
    17 Jun 2030

Specification

EUDAMED

Device Name
Faldelle Non Sterili/Sterilizzabili
Model / Reference
FALDELLE NON STERILI/STERILIZZABILI, FR3D0560X4INNBL, FR3D3030X4INABL, FR3D2020S4INN, FR3D4545X4IVABL, FR5D4040X4INA, FR3D4040S4INNBL, FR3D4570X4INNBL, FR3D2525X4INNBL, FR5D4570X4INABL, FR3D4545X4INABL, FR3D4570X4IVABL, FR3D2020X4INNBL, FR3D1060X4INABL, FR5D4545X4IXABL, FR5D3030F4SNA, FR3D0530X4INNBL, FR3D4570X4INABL, FR5D2525X4INA
Primary DI / UDI-DI
08011809021211, 08011809021280, 08011809021235, 08011809021358, 08011809021457, 08011809021303, 08011809021372, 08011809021273, 08011809021471, 08011809021334, 08011809021389, 08011809021259, 08011809021228, 08011809021464, 08011809021440, 08011809021198, 08011809021365, 08011809021426
Basic UDI-DI
8011809GAR6LAPNS2L
EMDN Code
M0201030102,M0201030202
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010188

Other devices from Santex S.p.A.

See all devices from Santex S.p.A. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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