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LithiX Hertz Contact Intravascular Lithotripsy Catheter
EUDAMEDClass III (EU MDR)
Ref DAR1514Ref DAR2514Ref DAR2714Ref DAR3014Ref DAR3214Ref DAR4014
Identity
- Trade Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter EUDAMED
- Device Name
- LithiX Hertz Contact Intravascular Lithotripsy Catheter EUDAMED
- Model / Reference
- DAR1514 EUDAMEDDAR2514 EUDAMEDDAR2714 EUDAMEDDAR3014 EUDAMEDDAR3214 EUDAMEDDAR4014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508014978 EUDAMED00817508015005 EUDAMED00817508015012 EUDAMED00817508015029 EUDAMED00817508015036 EUDAMED00817508017146 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 (6)
- EUDAMED d4d0e6ed-11d5-44b4-8f4f-96e2a1346d20 61 fields · synced Jul 30, 2026
- EUDAMED d00af8eb-741b-4a8d-8da8-3d8e8771a5a2 61 fields · synced May 17, 2026
- EUDAMED 7b81a8b8-0ee4-413f-9c26-9a513c649287 61 fields · synced May 18, 2026
- EUDAMED 1b9bd4ba-9965-41ad-977b-9c450e67b1b0 61 fields · synced May 18, 2026
- EUDAMED 673c5bbc-1c90-43bb-871d-d7a6e8655a80 61 fields · synced May 18, 2026
- EUDAMED 48f3e371-102f-4aa1-a6df-3adf3b24b28c 61 fields · synced May 19, 2026