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LithiX Hertz Contact Intravascular Lithotripsy Catheter
EUDAMEDClass III (EU MDR)
Ref DAR3514Model DAR1514
Identity
- Trade Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter EUDAMED
- Device Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter EUDAMED
- Model / Reference
- DAR1514 EUDAMEDDAR3514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508015043 EUDAMED
- Basic UDI-DI
- 081750801LithiXY7 EUDAMED
- EMDN Code
- C01040199 CARDIAC ANGIOGRAPHY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LithiX Hertz Contact Intravascular Lithotripsy Catheter by Elixir Medical Corporation — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081750801LithiXY7 | Class III | Active |
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Manufacturer
- Manufacturer
- Elixir Medical Corporation
- EUDAMED SRN
- US-MF-000013041
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED b30d3ec9-301c-4d3b-9225-f48198df5db8 61 fields · synced Jun 19, 2026