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Garze in Cotone Tagliate Senza Filo Rx Sterili

by Santex S.p.A. 3 variants

Ref AB3G1010AD, AB3G1515ADModel GARZE IN COTONE TAGLIATE SENZA FILO RX 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Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8011809GAR5TAGST43 Basic UDI-DI Date29 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  • Withdrawn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European Union — CE/MDR Withdrawn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

Model / Reference
GARZE IN COTONE TAGLIATE SENZA FILO RX STERILI, AB3G1010AD, AB3G1515AD
Primary DI / UDI-DI
08011809020733, 08011809020757
Basic UDI-DI
8011809GAR5TAGST43
EMDN Code
M0201010101 Cotton gauze, cut, without x-ray detectable thread, sterile
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