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Servator B Plus

by S.A.L.F. S.p.A. Laboratorio Farmacologico Italy EUDAMED

Ref HTKE1110GPO

EMDN C0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0004231724 Date29 Apr 2026IssuedStatusActive expires 19 Jan 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0004231724 Supplemented

    Quality management system EU MDR

    Issued
    29 Apr 2026
    Expires
    19 Jan 2028
    Reason
    Change approved
  • CVD005526 Issued

    Technical documentation EU MDR

    Issued
    5 Mar 2026
    Expires
    19 Jan 2028

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HTKE1110GPO
Primary DI / UDI-DI
08052742101127
Basic UDI-DI
805274210ServBPZD
EMDN Code
C0399 Cardiosurgery and organ transplantation devices - other
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010720

Other devices from S.A.L.F. S.p.A. Laboratorio Farmacologico

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    Class III
  • SalineSlush

    Class IIa
  • MethyBlue

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  • Servator H

    Class III
  • Pancreas LOCK S.A.L.F.

    Class IIb
  • Servator C

    Class III

See all devices from S.A.L.F. S.p.A. Laboratorio Farmacologico →

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 197ea1f9-a337-465e-a362-673eec2bd5be 61 fields · synced 22 Oct 2026