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Protek Duo+

by Sorin Group Italia S.r.L. 2 variants

Ref 5150-4629EU

Protek Duo+ (5150-4629EU) is a medical device (EU MDR Class III; EMDN category atriocaval cannulas) made by Sorin Group Italia S.R.L, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 8033178CANCVENOVENOCE) with CE/MDR certificate MDR 808216 (withdrawn), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033178CANCVENOVENOCE Basic UDI-DI 08033178019408UDI-DIDate7 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 808216 Cancelled

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    5 Feb 2026
    Expires
    4 Feb 2031
    Reason
    Other

Timeline

3 dated events

  1. Certificate issued EUDAMED MDR 808216
  2. Registered EUDAMED 8033178CANCVENOVENOCE
  3. Certificate expires EUDAMED MDR 808216

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Model / reference
5150-4629EU
Primary DI / UDI-DI
08033178019408
Basic UDI-DI
8033178CANCVENOVENOCE
EMDN code
C0301040201 Atriocaval cannulas
Device class
Class III
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027510

Similar devices in this category

Other devices filed under EXTRACORPOREAL CIRCULATION CANNULAS.

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Properties

  • Supplied sterile
Other properties (13, all answered No)