Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter

UDI-DI 00195451001192Basic UDI-DI 00195451C2AFIVLIPBS

Class III · MDR · Shockwave Medical Inc.

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Identification

Model: —
EMDN: C01040199
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

Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter 00195451001178
Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter 00195451001161
Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter 00195451001185

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/shockwave-c2-aero-fly-coronary-intravascular-lithotripsy-ivl-1192 · UDI page: /udi/00195451001192

All devices from Shockwave Medical Inc.

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