Manufacturer

Novocure

SwitzerlandLegal entities : Novocure GmbH

Markets : Czechia · Germany · Netherlands · Spain · United States

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

Public contracts won : Spain 10 · Czechia 3

EU representative : MDSS GmbH (Germany)

4 categories, 12 models including 11 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
General medicine therapeutic treatment instruments - consumables	Z12040285	INE Transducer Array - White INE9TAN, INE9TANW2 refs ITE Transducer array ITE1020W, ITE1020B, ITE1013W, ITE1013B3 refs ITE Transducer Array Large Black ITE1013B, ITE1013W, ITE1020B, ITE1020W3 refs ITE Transducer Array large – white ITE1020W, ITE1020B, ITE1013W, ITE1013B3 refs Optune HFE Transducer Array, black IHEP9020B, IHEP9020W2 refs 2 others Torso Applicator ACM000102 refs ILE Transducer Array Large - Black ILE1010, ILE1010W, ILE1030, ILE1030W6 refs (no longer marketed)	I, IIb MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - other	Z12040299	Optune Lua TFT92002 refs Optune Pax TFP9200 Optune TFH9100	IIb MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - hardware accessories	Z12040280	MyLink OTU5000	I MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - software accessories	Z12040282	NovoTAL flex 1.0	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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.