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PowerShock

by Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye EUDAMED

Ref 924961Model CIVL32512

EMDN C0104010206,C99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86843131CIVL325124J Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 273/MDR Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0051
    Issued
    20 Apr 2026
    Expires
    19 Apr 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Coronary Intravascular Lithotripsy Catheter
Model / Reference
CIVL32512, 924961
Primary DI / UDI-DI
08684313149612
Basic UDI-DI
86843131CIVL325124J
EMDN Code
C0104010206,C99
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000045382

Other devices from Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇ →

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 08684313149612|86843131CIVL325124J 61 fields · synced 24 Oct 2026