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Protek Duo+

by Sorin Group Italia S.r.L. United States EUDAMED

Ref 5150-5131EU

EMDN C0301040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033178CANCVENOVENOCE Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 808216 Cancelled

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    5 Feb 2026
    Expires
    4 Feb 2031
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
5150-5131EU
Primary DI / UDI-DI
08033178019446
Basic UDI-DI
8033178CANCVENOVENOCE
EMDN Code
C0301040201 Atriocaval cannulas
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027510

Other devices from Sorin Group Italia S.R.L

See all devices from Sorin Group Italia S.R.L →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08033178019446|8033178CANCVENOVENOCE 61 fields · synced 24 Oct 2026