Elixir Medical Corporation

Certificate 2024-MDR/TD-061/A

Rev. 02Supplemented

Valid until: Nov 8, 2029

Certificate 2024-MDR/TD-061/A is a valid Technical documentation issued to Elixir Medical Corporation and registered in EUDAMED. Valid until November 8, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/TD-061/A
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652024-MDR/TD-061/A02

Validity

Issued: Apr 22, 2026
Valid from: Apr 22, 2026
Valid until: Nov 8, 2029

Manufacturer

Manufacturer: Elixir Medical Corporation
Manufacturer SRN: US-MF-000013041
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

LithiX Hertz Contact Intravascular Lithotripsy CatheterClass III
081750801LithiXY7

Linked SSCPs

SSCP LBL00353

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

2024-MDR/TD-061Technical documentationAmendedApr 3, 2025 → Nov 8, 2029

Scope coverage

Class III1

1 scope

LithiX Hertz Contact Intravascular Lithotripsy Catheter
Class III
081750801LithiXY7

Documents

LanguagesEN