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Garze in Cotone Piegate Senza Filo Rx Sterili

by Santex S.p.A. 2 variants

Ref AA3S1840AS, AA3S3640AS, AA3F3640ASModel GARZE IN COTONE PIEGATE SENZA FILO RX STERILI

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8011809GAR5CPSTP4 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00155-A Active

    Quality management system EU MDR

    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  • Withdrawn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

Model / Reference
GARZE IN COTONE PIEGATE SENZA FILO RX STERILI, AA3S1840AS, AA3S3640AS, AA3F3640AS
Primary DI / UDI-DI
08011809020702, 08011809020719, 08011809000803
Basic UDI-DI
8011809GAR5CPSTP4
EMDN Code
M0201020101 Cotton gauzes, folded, 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