This page includes the latest FDA filings for Novocure G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010457505 |
| FEI Number | 3010457505 |
| Name | Mike Ambrogi |
| Owner & Operator | NOVOCURE GmbH |
| Contact Address | Business Village D4 Park 6 ROOT CH-LU Luzern 6039 CH |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 195 commerce way Portsmouth, NH 03801 US |
| Establishment Type | Repack or Relabel Medical Device |
Device Company | Device | Date |
|---|---|---|
| Novocure GmbH | Optune HFE transducer array white IHEP9020WUS | 2024-11-13 |
| Novocure GmbH | Optune HFE transducer array black IHEP9020BUS | 2024-11-13 |
| Novocure GmbH | NovoTAL flex SW000128 | 2024-11-13 |
| Novocure GmbH | Optune Lua (NovoTTF-200T) TFT9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Power Supply SPS9200US | 2024-10-18 |
| Novocure GmbH | Battery Charger for Optune Lua ICH9200US | 2024-10-18 |
| Novocure GmbH | Battery for Optune Lua IBH9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Connection Cable CAD9100US | 2024-10-18 |
| Novocure GmbH | Optune Lua (NovoTTF-200T) TFT9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Power Supply SPS9200US | 2024-10-18 |
| Novocure GmbH | Battery Charger for Optune Lua ICH9200US | 2024-10-18 |
| Novocure GmbH | Battery for Optune Lua IBH9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Connection Cable CAD9100US | 2024-10-18 |
| Novocure GmbH | Optune Lua (NovoTTF-200T) TFT9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Power Supply SPS9200US | 2024-10-18 |
| Novocure GmbH | Battery Charger for Optune Lua ICH9200US | 2024-10-18 |
| Novocure GmbH | Battery for Optune Lua IBH9200US | 2024-10-18 |
| Novocure GmbH | Optune Lua Connection Cable CAD9100US | 2024-10-18 |
| Novocure GmbH | ITE Transducer Arrays Large White Connector ITE1020WUS | 2024-10-17 |
| Novocure GmbH | ITE Transducer Arrays Large Black Connector ITE1020BUS | 2024-10-17 |
| Novocure GmbH | ITE Transducer Arrays Small White Connector ITE1013WUS | 2024-10-17 |
| Novocure GmbH | ITE Transducer Arrays Small White Connector ITE1013BUS | 2024-10-17 |
| Novocure GmbH | MAXPOINT BR-I SW000060 | 2024-08-16 |
| Novocure GmbH | ILE Transducer Arrays Large White Connector ILE1030WUS | 2024-04-18 |
| Novocure GmbH | ILE Transducer Arrays Large White Connector ILE1030US | 2024-04-18 |
| Novocure GmbH | ILE Transducer Arrays Small White Connector ILE1010WUS | 2024-04-18 |
| Novocure GmbH | ILE Transducer Arrays Small Black Connector ILE1010US | 2024-04-18 |
| Novocure GmbH | Battery for Optune GIO IBH9100US | 2024-04-18 |
| Novocure GmbH | Battery for Optune GIO IBH9100US | 2024-04-18 |
| Novocure GmbH | Battery for Optune GIO IBH9100US | 2024-04-18 |
| Novocure GmbH | NovoTAL Software for Array Mapping SW000011 | 2024-04-18 |
| Novocure GmbH | Optune System | 2021-05-24 |
| Novocure GmbH | Optune System | 2021-03-09 |
| Novocure GmbH | Optune System | 2021-03-09 |
| Novocure GmbH | INE Transducer Arrays Tan Plaster and Black Connector INE9020US | 2021-02-10 |
| Novocure GmbH | Power Supply for NovoTTF-100L SPS9050US | 2020-12-17 |
| Novocure GmbH | ILE Transducer Arrays Large White Connector ILE9030WUS | 2020-12-17 |
| Novocure GmbH | ILE Transducer Arrays Large White Connector ILE9030US | 2020-12-17 |
| Novocure GmbH | ILE Transducer Arrays Small White Connector ILE9010WUS | 2020-12-17 |
| Novocure GmbH | Connection Cable for NovoTTF-100L CAD9050US | 2020-12-16 |
| Novocure GmbH | Portable Battery for NovoTTF-100L IBH9050US | 2020-12-16 |
| Novocure GmbH | ILE Transducer Arrays Small Black Connector ILE9010US | 2020-12-16 |
| Novocure GmbH | NovoTTF-100L Portable Battery Rack PBR9050US | 2020-12-15 |
| Novocure GmbH | Portable Battery Charger ICH9050US | 2020-12-15 |
| Novocure GmbH | NovoTTF-100L TFL9050US | 2020-12-15 |
| Novocure GmbH | INE Transducer Arrays Tan Plaster and Black Connector INE9020US | 2020-08-27 |
| Novocure GmbH | Optune System | 2020-03-15 |
| Novocure GmbH | INE Transducer Arrays White Connector INE9000W | 2019-05-13 |
| Novocure GmbH | INE Transducer Array Black Connector INE9000 | 2019-05-13 |
| Novocure GmbH | Device Bag for the Optune 90002 | 2019-04-24 |
| Novocure GmbH | Optune 90051 | 2019-04-24 |
| Novocure GmbH | Power Supply for Optune 90046 | 2019-04-24 |
| Novocure GmbH | Optune Porteable Battery Rack 90039 | 2019-04-24 |
| Novocure GmbH | Optune Porrtable Battery Charger 90023 | 2019-04-24 |
| Novocure GmbH | Portable Battery for Optune 90019 | 2019-04-24 |
| Novocure GmbH | Connection Cable for Optune 90009 | 2019-04-24 |
| Novocure GmbH | Connection Cable for Optune CAD9100US | 2018-09-05 |
| Novocure GmbH | Optune TFH9100US | 2018-09-05 |
| Novocure GmbH | Device Bag for Optune BAG9100US | 2018-09-05 |
| Novocure GmbH | Power Supply for Optune SPS9100US | 2018-09-05 |
| Novocure GmbH | Optune Porrtable Battery Charger ICH9100US | 2018-09-05 |
| Novocure GmbH | Battery for Optune IBH9100US | 2018-09-05 |
| Novocure GmbH | NovoTAL Software for Array Mapping 90094 | 2018-07-06 |
| Novocure GmbH | INE Transducer Arrays White Connector INE9000W | 2018-07-06 |
| Novocure GmbH | Novocure Ltd.'s Optune | 2017-03-15 |
| Novocure GmbH | OPTUNE | 2016-07-13 |
| Novocure GmbH | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | 2016-03-18 |
| Novocure GmbH | NOVOCURE'S OPTUNE SYSTEM | 2016-02-09 |
| Novocure GmbH | OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM) | 2015-10-05 |
| Novocure GmbH | NOVOTTF-100A SYSTEM | 2015-03-23 |
| Novocure GmbH | NOVA TTF-100A SYSTEM | 2015-03-17 |
| Novocure GmbH | NOVOTFF-100A SYSTEM | 2014-11-12 |
| Novocure GmbH | OPTUNE | 2014-09-28 |
| Novocure GmbH | NOVOTTF-100A TREATMENT KIT | 2014-07-25 |
| Novocure GmbH | NOVO TTF-100A SYSTEM | 2014-07-24 |
| Novocure GmbH | NOVOTTF-100A SYSTEM | 2013-09-19 |
Mike Ambrogi [NOVOCURE GmbH] | INE transducer arrays for NovoTTF-100A treatment kit; NovoTTF-100A treatment kit | 2013-08-12 |
| Novocure GmbH | NOVOTTF-100A SYSTEM | 2013-08-08 |
| Novocure GmbH | NOVA TTF-100A SYSTEM | 2013-06-12 |
| Novocure GmbH | NOVOTTF-100A SYSTEM | 2013-04-17 |
| Novocure GmbH | NOVOTTF-100A SYSTEM | 2012-12-03 |
| Novocure GmbH | NOVOCURE NOVOTTF-100A SYSTEM | 2012-01-03 |
| NCAGE Code | SEFK2 | NOVOCURE GMBH |
| CAGE Code | SEFK2 | NOVOCURE GMBH |