FDA Registration
Active
🇨🇭 Switzerland
NOVOCURE GMBH
Reg #: 3010457505
·
FEI: 3010457505
·
Expires 2026
Products
4
Proprietary Names
10
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NOVOCURE GMBH
- Registration Number
- 3010457505
- FEI Number
- 3010457505
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Neuhofstrasse 21
- City
- Baar Zug
- Country
- CH
Regulatory Submissions
- PMA Number
- P100034
Owner / Operator
- Firm Name
- NOVOCURE GmbH
- Operator Number
- 10044866
- Address
- Neuhofstrasse 21
- City
- Baar
- State
- Zug
- Postal Code
- 6340
- Country
- CH
- Correspondent
- Lori Burns
US Agent
- Business Name
- NOVOCURE INC.
- Contact Name
- Jennifer Henderson
- Address
- 1550 Liberty Ridge Dr Ste 115
- City
- Chesterbrook
- State
- PA
- ZIP
- 19087
- Country
- US
- [email protected]
- Phone
- 603 5014290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Low Electric Field, Tumor Treatment | NZK | Class 3 | Unknown | No | 2013-08-12 |
| Low Electric Field Generator For Pancreatic Cancer Treatment | SHC | Class 3 | Unknown | No | 2026-02-12 |
| Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | SDA | Class 3 | Unknown | No | 2024-10-17 |
| Electrical Tumor Treatment Fields | QGZ | Class 3 | Unknown | No | 2020-09-23 |
Proprietary Names
INE Transducer Array
Optune Treatment kit
MAXPOINT BR-I
NovoTAL flex
Optune HFE transducer array
Optune Pax
Optune Lua
Optune Lua Treatment Kit
ILE Transducer Arrays
ITE Transducer Array
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device