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by SXT S.r.l. - Sistemi per Telemedicina Italy EUDAMED

Ref BVWX

EMDN Z1203019092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805771725BLUEVIEW9G Basic UDI-DIDate15 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030126-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    25 Feb 2025
    Expires
    24 Feb 2030

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
BVWX
Primary DI / UDI-DI
08057717250060
Basic UDI-DI
805771725BLUEVIEW9G
Direct Marketing DI
08057717250060
EMDN Code
Z1203019092 Various instruments for anaesthesia and pulmonary ventilation support - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000020871

Other devices from SXT S.r.l. - Sistemi per Telemedicina

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 05661251-2f70-4089-a261-deb5794a66ad 61 fields · synced 23 Oct 2026