Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010457505

FEI Number

3010457505

Entity Name

NOVOCURE GMBH

City/State/Country

Baar Zug, CH

Establishment Address

Neuhofstrasse 21, Baar Zug 6340, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

NOVOCURE GmbH (Owner Number: 10044866)

Owner / Operator Contact Address

Neuhofstrasse 21, Baar, CH-ZG 6340, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100034

All Registered Proprietary Names

INE Transducer Array Optune Treatment kit MAXPOINT BR-I NovoTAL flex Optune HFE transducer array

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NZK	Stimulator, Low Electric Field, Tumor Treatment	Unknown	Class 3	N/A	2013-08-12

Official Correspondent

Lori Burns

US Agent Details

Jennifer Henderson Business: NOVOCURE INC. Email: jhenderson@novocure.com Phone: (603) 5014290

Related Public Records

Same Entity

NOVOCURE GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3009453079	NOVOCURE LTD	Haifa Northern, IL
3010291427	AvailMed S.A.De C.V.	Tijuana Baja California, MX
8043792	STERIS Schweiz AG	Daniken Solothurn, CH
3003639781	A.L. ELECTRONICS LTD.	YEHUD Central, IL
3009306483	NOVOCURE INC	Portsmouth, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010457505. Last updated year: 2026. Please use registration number 3010457505 when referencing this establishment in official correspondence.