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ShockFast

by Shunmei Medical Co., Ltd 24 variants

Ref 631185, 631159, 631171, 631158, 631183, 629960, 629961, 631150, 631182, 629953, 629965, 631153, 631173, 631144, 631152, 629967, 630587, 631174, 631149, 631181, 631177, 631180, 631154, 630585, 629954, 630563, 630562, 631176, 631148, 631155, 629952, 630586, 631175Model 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 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  • Withdrawn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
Peripheral Intravascular Lithotripsy Catheter
Coronary Intravascular Lithotripsy Catheter
Model / Reference
631185, 631159, 631171, 631158, 631183, 629960, 629961, 631150, 631182, CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015, 629953, 629965, 631153, 631173, 631144, 631152, 629967, 630587, 631174, 631149, 631181, 631177, 631180, 631154, 630585, 629954, 630563, 630562, 631176, 631148, 631155, 629952, 630586, 631175
Primary DI / UDI-DI
06956014411858, 06956014411599, 06956014411711, 06956014411582, 06956014411834, 06956014499603, 06956014499610, 06956014411506, 06956014411827, 06956014499535, 06956014499658, 06956014411537, 06956014411735, 06956014411445, 06956014411520, 06956014499672, 06956014405871, 06956014411742, 06956014411490, 06956014411810, 06956014411773, 06956014411803, 06956014411544, 06956014405857, 06956014499542, 06956014405635, 06956014405628, 06956014411766, 06956014411483, 06956014411551, 06956014499528, 06956014405864, 06956014411759
Basic UDI-DI
69560144PILCUK, 69560144CILCRQ
Direct Marketing DI
06956014411858
06956014411599
06956014411711
06956014411582
06956014411834
06956014499603
06956014499610
06956014411506
06956014411827
06956014499535
06956014499658
06956014411537
06956014411735
06956014411445
06956014411520
06956014499672
06956014405871
06956014411742
06956014411490
06956014411810
06956014411773
06956014411803
06956014411544
06956014405857
06956014499542
06956014405635
06956014405628
06956014411766
06956014411483
06956014411551
06956014499528
06956014405864
06956014411759
EMDN Code
C010402020101, C010401020101
Device Class
Class IIb
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: Peripheral angioplasty balloon catheter, basic

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Properties

  • Sterile YesEUDAMEDNoEUDAMED

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