FDA Registration
Active
🇮🇱 Israel
Optune Lua Treatment Kit
Reg #: 3009453079
·
FEI: 3009453079
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOVOCURE LTD
- Registration Number
- 3009453079
- FEI Number
- 3009453079
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Topaz Bldg., Matam Center
- City
- Haifa Northern
- Country
- IL
Regulatory Submissions
- PMA Number
- H180002
Owner / Operator
- Firm Name
- Novocure
- Operator Number
- 10039906
- Address
- Topaz Bldg , 4th floor, Matam Center
- City
- Haifa
- State
- Northern
- Postal Code
- 31905
- Country
- IL
- Correspondent
- Relu Segal
US Agent
- Business Name
- Novocure Inc
- Contact Name
- Jennifer Henderson
- Address
- 1550 Liberty Ridge Dr., Suite 115
- City
- Wayne
- State
- PA
- ZIP
- 19087
- Country
- US
- [email protected]
- Phone
- 603 5014290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrical Tumor Treatment Fields | QGZ | Class 3 | Unknown | No | 2019-12-06 |
Proprietary Names
Optune Lua Treatment Kit
Transducer Array
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility