Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Exablate 4000 Patient Treatment Kit

UDI-DI 07290019402015Basic UDI-DI 7290015461Ex4000-PPTX

Class IIb · MDR · InSightec Ltd.

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Identification

Model: Exablate 4000
EMDN: Z120610
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

SRN IL-MF-000011795

IL · Tirat Carmel

manufacturer

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

Related UDI-DIs

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Exablate 4000 Patient Treatment Kit 07290019402039
Exablate 4000 Patient Treatment Kit 07290019402091
Exablate 4000 Patient Treatment Kit 07290019402749
Exablate 4000 Patient Treatment Kit 07290019402077
Exablate 4000 Patient Treatment Kit 07290019402053
Exablate 4000 Treatment Accessories Kit 07290019402572
Head Frame Set for Exablate 4000 Type 1.0 Systems 07290019402107
Head Frame Set for Exablate 4000 Type 1.1 Systems 07290019402114
Head Frame Set for Exablate 4000 Type 1.1 Systems 07290019402701
Head Frame Set for Type 1.0 Systems 07290019402459

Showing 12 of 13 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/exablate-4000-patient-treatment-kit-2015 · UDI page: /udi/07290019402015

All devices from InSightec Ltd.

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