INSIGHTEC
Sistemas de ultrasonido enfocado guiados por Mr para cirugía sin incisiones.
INSIGHTEC fabrica sistemas de ultrasonido enfocado guiados por resonancia magnética para cirugía sin incisiones en sus operaciones de Haifa. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Haifa, Israel
- Founded
- 1999
- Website
- insightec.com
- Categories
- Suministros médicos y sanitarios, Electrónica de consumo
- Markets
- Israel, Estados Unidos, Alemania, Japón
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)