Manufacturer

InSightec

IsraelLegal entities : InSightec Ltd.

Markets : Germany · Italy · United States

Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 2 · PMA : 3 · class II, III · latest in 2026 · see on the FDA website

Public contracts won : Germany 2

EU representative : Obelis s.a. (Belgium)

1 category, 9 models including 9 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Ultrasound therapy equipment	Z120610	3 Treatment Water Kit Degassed Water 1L Pouch Exablate 2100V1 Exablate 2100V1 Prostate Treatment Kit Exablate 40003 refs 4 others Exablate 4000 Patient Treatment Kit3 refs Exablate Scar Patch Gel Pad 15mm3 refs Patient Accessories Kit SET000016-CE	I, IIb MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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