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Sep4Angio

by NOVYSTEM S.p.A. Italy EUDAMED

Ref NS-STEM-33

EMDN B0599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805571348SEP4ANGIO00UB Basic UDI-DIDate16 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030023-00 Withdrawn

    Quality assurance EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    28 Apr 2023
    Expires
    27 Apr 2028
    Reason
    Not on market

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
NS-STEM-33
Primary DI / UDI-DI
08055713480009
Basic UDI-DI
805571348SEP4ANGIO00UB
EMDN Code
B0599 Topical use blood components preparation devices - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000032699

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 b4d4e506-d1c7-4149-a889-1feba3acc06f 61 fields · synced 22 Oct 2026