InSightec Ltd.

Certificate 3902589CE01

Rev. 6Reissued

Valid until: Feb 1, 2031

Certificate 3902589CE01 is a valid Quality management system issued to InSightec Ltd. and registered in EUDAMED. Valid until February 1, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 3902589CE01
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03443902589CE016

Validity

Issued: Feb 1, 2026
Valid from: Feb 1, 2026
Valid until: Feb 1, 2031

Manufacturer

Manufacturer: InSightec Ltd.
Manufacturer SRN: IL-MF-000011795
Manufacturer country: Israel

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Characteristics

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

History

Supersedes

3902589CE01AmendedAug 31, 2023 → Feb 1, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2

2 scopes

DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN