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Z-5 Atrioseptostomy

by NuMED, Inc. United States EUDAMED

Ref SPT002Model 210 / 212

EMDN C0199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08877141300SK Basic UDI-DIDate28 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • US24/00000499 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 1639
    Issued
    7 Aug 2025
    Expires
    6 Dec 2029

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Atrioseptostomy Devices
Model / Reference
210 / 212, SPT002
Primary DI / UDI-DI
10887714000123
Basic UDI-DI
08877141300SK
EMDN Code
C0199 Arterio-venous devices - other
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000010948
Authorised representative
EVOMED S.L.U. ES-AR-000047116

Other devices from NuMED, Inc.

See all devices from NuMED, Inc. →

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 10887714000123|08877141300SK 61 fields · synced 24 Oct 2026