FDA.reportPublic FDA data

NOVOCURE GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104575053010457505NOVOCURE GMBH1N2026-01-01Neuhofstrasse 21 Baar Zug CH 6340

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290107985352ITE Transducer Arrays Small Black Connector - ITE1013B1-855-281-9301support@novocure.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1618041621540556P250034Optune PaxSHC2026-02-11
1618041046377550P230042Optune LuaSDA2024-10-15
1618041313433202P100034NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNZK2011-04-08
1618041737344825H180002

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NZK12011-04-08

PMA#

Optune® device

2022-05-10

Novocure GmbHpark 6ch-6039 Root D4  PMA NumberP100034 Supplement NumberS029 Date Received02/14/2022 Decision Date05/10/2022 Product Code NZK  Advisory Committee Neurology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifi...

GUDID#

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