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Blunotte 2 Cloud Auto

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

Ref ACPT2Model MCPA

EMDN Z12030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805771725BLUNOTTED2 Basic UDI-DIDate17 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030074-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    10 May 2024
    Expires
    9 May 2029

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Blunotte 2
Model / Reference
MCPA, ACPT2
Primary DI / UDI-DI
08057717250022
Basic UDI-DI
805771725BLUNOTTED2
Direct Marketing DI
08057717250022
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000020871

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

  • Blueviewer Web

    Class IIa

  • Blunotte 2 Auto

    Class IIa

  • Blunotte 2 Cloud

    Class IIa

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 f9ad02f5-2c23-472d-b309-81a2a2c593a9 61 fields · synced 22 Oct 2026