Skip to content

PowerShock

by Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇ 48 variants

Ref 925603Model PIVL18-40800

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86843131PIVL18-40800VT Basic UDI-DI 08684313156030UDI-DIDate10 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Peripheral Intravascular Lithotripsy Catheter
Model / Reference
PIVL18-40800, 925603
Primary DI / UDI-DI
08684313156030
Basic UDI-DI
86843131PIVL18-40800VT
EMDN Code
C010402020101, C0104020210
Device Class
Class IIb
EU 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

  • 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