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Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Exablate 4000 Prime

UDI-DI 07290019402558Basic UDI-DI 7290015461Ex4000-SYSFB

Class IIb · MDR · InSightec Ltd.

Identification
Model
4000
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

3902589CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-02-01 · Expiry 2031-02-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

InSightec Ltd.

SRN IL-MF-000011795

IL · Tirat Carmel

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/exablate-4000-prime-2558 · UDI page: /udi/07290019402558

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