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PULSTA™ Transcatheter Pulmonary Valve System

by Taewoong Medical Co., Ltd. South Korea EUDAMED

Ref TPV2438Model TPV1828

EMDN P070301030103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880964375TPVWW Basic UDI-DIDate19 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 796279 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    21 Jan 2026
    Expires
    20 Jan 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Transcatheter Pulmonary Valve
Model / Reference
TPV1828, TPV2438
Primary DI / UDI-DI
08809643759663
Basic UDI-DI
880964375TPVWW
EMDN Code
P070301030103 Stented biological pulmonary valves for percutaneous implant - valve tissue of animal origin
Device Class
Class III
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000007515
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • CMR Substance
  • Animal Tissues
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08809643759663|880964375TPVWW 61 fields · synced 24 Oct 2026