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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter

UDI-DI 00195451000652Basic UDI-DI 00195451C2AIVLIP49

Class III · MDR · Shockwave Medical Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 728474

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-22 · Expiry 2027-08-17

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Shockwave Medical Inc.

SRN US-MF-000012770

US · Santa Clara, CA

manufacturer

Authorised representative: ICON (LR) Limited (IE-AR-000006507)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/shockwave-c2-aero-coronary-intravascular-lithotripsy-ivl-cat-0652 · UDI page: /udi/00195451000652

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