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Novocure GmbH

Switzerland·CH-MF-000029002

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Optune Gio	TFH9100EU	EUDAMED	Class IIb	Active
INE Transducer Array- Black	INE9020	EUDAMED	Class IIb	Active
ILE Transducer Array Small - White	ILE1010WEU	EUDAMED	Class IIb	Active
Optune HFE Transducer Array, black	IHEP9020BEU	EUDAMED	Class IIb	Active
ILE Transducer Array Small - Black	ILE2010EU	EUDAMED	Class IIb	Active
Optune HFE Transducer Array, white	IHEP9020WEU	EUDAMED	Class IIb	Active
ILE Transducer Array Large - Black	ILE2030EU	EUDAMED	Class IIb	Active
flex transducer array, white	IHEP9020WEU	EUDAMED	Class IIb	Active
NovoTAL flex	SW000128	EUDAMEDFDA UDI	Class IIb	Active
ILE Transducer Array Large - Black	ILE1030EU	EUDAMED	Class IIb	Active
MyLink	OTU5000EU	EUDAMED	Class I	Active
Torso Applicator	ACM00012EU	EUDAMED	Class I	Active
INE Transducer Array - White	INE9020W	EUDAMED	Class IIb	Active
Optune Pax	P250034	FDA PMA	Class III	Active
Optune Lua®	P230042	FDA PMA	Class III	Active
Novo Ttf-100a System	P100034	FDA PMA	Class III	Active
ILE Transducer Array Large - White	ILE2030WEU	EUDAMED	Class IIb	Active
Optune Lua	TFT9200EU	EUDAMED	Class IIb	Active
flex transducer array, black	IHEP9020BEU	EUDAMED	Class IIb	Active
ILE Transducer Array Small - Black	ILE1010EU	EUDAMED	Class IIb	Active

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Establishments registered with the FDA under this company group, matched by name.