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LiqMagic C14

by Sonosemi Medical Co., Ltd. 7 variants

Ref SI-SC001-32512Model SI-SC001-25012

Active European Union

CE MDR

Valid until

8 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 NumberMDR 813398 Date22 Jun 2026IssuedStatusActive expires 8 Apr 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 813398 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    22 Jun 2026
    Expires
    8 Apr 2031
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Coronary Intravascular Lithotripsy Catheter
Model / Reference
SI-SC001-25012, SI-SC001-32512
Primary DI / UDI-DI
06974215910048
Basic UDI-DI
697421591SC001EL
EMDN Code
C010401020199 Ptca dilatation catheters - other
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000042188
Authorised representative
PureCE B.V. NL-AR-000006069

Other devices from Sonosemi Medical Co., Ltd.

  • LiqMagic C14

    Class III

  • LiqMagic C14

    Class III

  • LiqMagic C14

    Class III

  • LiqMagic C14

    Class III

  • LiqMagic C14

    Class III

  • LiqMagic C14

    Class III

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