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LithiX Hertz Contact Intravascular Lithotripsy Catheter [EN]
EUDAMEDClass III (EU MDR)
Ref DAR2014Model DAR1514
Identity
- Trade Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter [EN] EUDAMED
- Device Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter EUDAMED
- Model / Reference
- DAR1514 EUDAMEDDAR2014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508014985 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 [EN] 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 d3426b72-9a38-4de3-87ff-c5e51e253e2d 61 fields · synced Jul 13, 2026