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Garze in Cotone Laparotomiche Sterili

by Santex S.p.A. 20 variants

Ref FEFL4040F4N0505Model GARZE LAPAROTOMICHE STERILI

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 Number8011809GAR6LAPST35 Basic UDI-DI 08011809021150UDI-DIDate28 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Garze Laparotomiche Sterili
Model / Reference
GARZE LAPAROTOMICHE STERILI, FEFL4040F4N0505
Primary DI / UDI-DI
08011809021150
Basic UDI-DI
8011809GAR6LAPST35
EMDN Code
M0201030101, M0201030201
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

  • Sterile

Other properties (12)

  • 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