HomeIsraelINSIGHTEC, LTD.

INSIGHTEC, LTD.

Israel · Tirat Carmel
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 1Class III 3
plus 5 registration records and 2 510(k), 72 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
2valid device licences
Class II 1Class III 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
3active registrations
Class 2b 2Class 3 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 2 510(k), 72 PMA, 2 excluded
Manufacturer names merged into this page: INSIGHTEC, LTD. · INSIGHTEC LTD.

Company information

Country
Israel
City
Tirat Carmel

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
INSIGHTEC LTD
Company number
512755745
Registration status
Active
Incorporated
1999-03-09

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12021 · K212150
12023 · K231378

FDA listed device types

High Intensity Ultrasound System For Prostate Tissue Ablation 1Mr-Guided Focused Ultrasound System 1Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided 1Ultrasound, Hyperthermia, Cancer Treatment 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.02023-10-30
USK212150Exablate Prostate System2021-11-23

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