INSIGHTEC
Sistemi ad ultrasuoni focalizzati guidati da Mr per la chirurgia senza incisione.
INSIGHTEC produce sistemi ad ultrasuoni focalizzati guidati da RM per la chirurgia senza incisione dalle sue sedi di Haifa. L'azienda fornisce sistemi sanitari, laboratori, partner OEM o clienti esportatori regolamentati nei suoi mercati primari quotati.
- Type
- brand seeking distribution
- Location
- Haifa, Israel
- Founded
- 1999
- Website
- insightec.com
- Categories
- Forniture medicali e sanitarie, Elettronica di consumo
- Markets
- Israele, Stati Uniti, Germania, Giappone
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- domain-registered (green), checked 2026-08-08 Domain registry record
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)