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ShockFast

by Shunmei Medical Co., Ltd 4 variants

Ref 630561Model CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015

Active European Union

CE MDR

Valid until

15 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Adriatic d.o.o.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberM.2025.MDR.2017 Date18 May 2026IssuedStatusActive expires 15 May 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • M.2025.MDR.2017 Active Amended

    Technical documentation EU MDR

    Certifier
    UDEM Adriatic d.o.o. 2696
    Issued
    18 May 2026
    Expires
    15 May 2028
    Reason
    Other

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  • Withdrawn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
CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015, 630561
Primary DI / UDI-DI
06956014405611
Basic UDI-DI
69560144CILCRQ
Direct Marketing DI
06956014405611
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000001160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from Shunmei Medical Co., Ltd

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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