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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

LithiX Hertz Contact Intravascular Lithotripsy Catheter

UDI-DI 00817508015036Basic UDI-DI 081750801LithiXY7

Class III · MDR · Elixir Medical Corporation

Identification
Model
DAR1514
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2024-MDR/TD-061/A

EU technical documentation assessment · unknown

Notified body: 3EC International a.s. (2265)

Valid from 2026-04-22 · Expiry 2029-11-08

Scope not stated in certificate data.

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

2024-MDR/QS-061/A

EU quality management system · unknown

Notified body: 3EC International a.s. (2265)

Valid from 2026-04-22 · Expiry 2029-11-08

Scope not stated in certificate data.

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

Manufacturer

Elixir Medical Corporation

SRN US-MF-000013041

US · Milpitas

manufacturer

Authorised representative: Acorn Regulatory Consultancy Services Ltd (IE-AR-000000592)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lithix-hertz-contact-intravascular-lithotripsy-catheter-5036 · UDI page: /udi/00817508015036

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