INSIGHTEC
Mr-geführte fokussierte Ultraschallsysteme für inzisionslose Chirurgie.
INSIGHTEC stellt am Standort Haifa MR-gesteuerte fokussierte Ultraschallsysteme für die inzisionslose Chirurgie her. Das Unternehmen beliefert Gesundheitssysteme, Labore, OEM-Partner oder regulierte Exportkunden in seinen aufgeführten Hauptmärkten.
- Type
- brand seeking distribution
- Location
- Haifa, Israel
- Founded
- 1999
- Website
- insightec.com
- Categories
- Medizin- & Gesundheitsbedarf, Unterhaltungselektronik
- Markets
- Israel, Vereinigte Staaten, Deutschland, Japan
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)