Data / Medical devices / Switzerland / Novocure GMBH
Novocure GMBH: FDA-registered device maker in Baar Zug, Switzerland, 3 PMA approvals
Novocure GMBH is registered with the FDA (registration 3010457505) in Baar Zug, Switzerland. It lists 4 device types. The FDA files 3 PMA approvals under its listings, the newest dated February 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010457505
- Address
- Neuhofstrasse 21, Baar Zug, Switzerland, 6340
- Owner or operator
- NOVOCURE GmbH (10044866)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 12, 2013
- Registered through
- 2027
- Brand names listed
- ILE Transducer Arrays, INE Transducer Array, ITE Transducer Array, MAXPOINT BR-I, NovoTAL flex, Optune HFE transducer array, Optune Lua, Optune Lua Treatment Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrical Tumor Treatment Fields | QGZ | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | SDA | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Low Electric Field Generator For Pancreatic Cancer Treatment | SHC | 3 | Manufacturer | accessdata.fda.gov |
| Stimulator, Low Electric Field, Tumor Treatment | NZK | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2026 | P250034 | Optune Pax | SHC | 1 | July 1, 2026 | accessdata.fda.gov |
| October 15, 2024 | P230042 | Optune Lua | SDA | 6 | July 1, 2026 | accessdata.fda.gov |
| April 8, 2011 | P100034 | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | NZK | 45 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Electrical Tumor Treatment Fields
- All makers of Low Electric Field Generator For Pancreatic Cancer Treatment
- All makers of Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
- All makers of Stimulator, Low Electric Field, Tumor Treatment
Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.