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PULSTA™ Transcatheter Pulmonary Valve System

by Taewoong Medical Co., Ltd. EUDAMED

Active European Union

Ref RSS20Model RSS18

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880990940RSSWN Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Crimping Tool
Model / Reference
RSS18, RSS20
Primary DI / UDI-DI
08809909406188
Basic UDI-DI
880990940RSSWN
EMDN Code
P07038002 Cardiac valve transcatheter implant accessories
Device Class
Class I
Market of Registration
Poland

Manufacturer details

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

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Properties

  • 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