Insightec Ltd
Active in EUDAMEDIsraelfrom SRN EUDAMED FDA SRN IL-MF-000011795
Insightec Ltd is a medical device manufacturer based in Israel, with 104 devices listed in 4 registries (FDA Class III and II; EU Class IIb and I) as of 15 Nov 2026.
- Devices
- 104
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 80
- EUDAMED 27
- FDA 510(k) 1
- FDA PMA 1
- Device classes
- FDA Class III 80
- EU Class IIb 15
- EU Class I 7
- FDA Class II 2
- Top EMDN categories
- Sites and related companies
- Obelis S.A. authorised representative
- Identifiers
- EUDAMED SRN IL-MF-000011795
- DUNS 532169513
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- Obelis S.A.BE
What Insightec Ltd makes
Insightec Ltd manufactures gel pads for ultrasound-guided procedures, including a standard 15mm pad and a larger 45mm bowl-shaped variant, as well as water treatment kits for therapeutic applications. Their portfolio includes focused ultrasound systems, such as the Exablate 2100V1 and Exablate Prostate System, designed for non-invasive tissue ablation, alongside accessories like the Exablate Scar Patch for post-treatment care. Additional devices include the Exablate MRgFUS system for MRI-guided focused ultrasound and the Exablate 2000 System, specifically for uterine fibroid ablation.
The company’s products span Class I, Class II, and Class III medical devices under global regulatory frameworks, with listings in the EU’s EUDAMED database, the FDA’s 510(k) and PMA clearance registries. These systems are intended for use in procedures requiring precise ultrasound energy delivery, often under MRI guidance, and are authorised for commercial distribution in markets adhering to these regulatory standards.
Catalogue
Search and filter all 104 devicesShowing 1-50 of 104
Company details
- EUDAMED SRN
- IL-MF-000011795
- DUNS number
- 532169513
- EU VAT number
- 512755745
- EUDAMED status
- Active
- EUDAMED registered name
- InSightec Ltd.
- Registered address
- 5, Nachum Heth, 3912001, Tirat Carmel, Israel
- Phone
- 18663922528
- PRRC contact
- Dorit Nahari
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Feb 2031
DEKRA Certification B.V. 0344 1 certificate
- 3902589CE01 Active
Quality management system EU MDR
- Issued
- 1 Feb 2026
- Expires
- 1 Feb 2031
FDA establishments
- Insightec US
Frequently asked questions
How many devices does INSIGHTEC LTD have in the registry?
The registry currently lists 104 devices for INSIGHTEC LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list INSIGHTEC LTD's devices?
Among its 50 most recently registered devices, INSIGHTEC LTD has devices listed in EUDAMED (22 devices) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do INSIGHTEC LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for INSIGHTEC LTD's devices are Class I, Class IIb and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for INSIGHTEC LTD?
EUDAMED lists 1 certificate for INSIGHTEC LTD (quality management system) under MDR. The most recent was issued on 1 Feb 2026.
What are the newest devices from INSIGHTEC LTD in the registry?
The most recently registered devices listed for INSIGHTEC LTD include Head Frame Set for Type 1.0 Systems, Patient Accessories Kit, Exablate 4000 Accessories and Treatment Kits and Head Frame Set for Exablate 4000 Type 1.0 Systems.
Which FDA establishments are linked to INSIGHTEC LTD?
1 FDA establishment is linked to INSIGHTEC LTD in the registry; they are listed on the company page.