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Garze Laparotomiche Non Sterili

by Santex S.p.A. EUDAMED

Active European Union

Ref FR3D2020X4INABLModel FALDELLE NON STERILI/STERILIZZABILI

Regulatory status

as of 26 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  • Withdrawn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, FR3D2020X4INABL
Primary DI / UDI-DI
08011809021242
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

Show 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