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Garze Laparotomiche Non Sterili

by Santex S.p.A. 12 variants

Ref FR5D2020X4INAModel FALDELLE NON STERILI/STERILIZZABILI

Active European Union

CE MDR

Valid until

17 Jun 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8011809GAR6LAPNS2L Basic UDI-DI 08011809021419UDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00155-A Active

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Faldelle Non Sterili/Sterilizzabili
Model / Reference
FALDELLE NON STERILI/STERILIZZABILI, FR5D2020X4INA
Primary DI / UDI-DI
08011809021419
Basic UDI-DI
8011809GAR6LAPNS2L
EMDN Code
M0201030102, M0201030202
Device Class
Class IIa
EU 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