Novocure GmbH
CH-MF-000029002 · Switzerland · Baar
Novocure GmbH is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 24 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: 1.0, ACM00010, IHEP9020B, IHEP9020W, ILE1010, ILE1010W, ILE1030, ILE1030W, INE9TAN, INE9TANW.
Among these devices, 16 are declared sterile, 25 active.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- ILE Transducer Array Large - Black
- ILE Transducer Array Large - White
- ILE Transducer Array Small - Black
- INE Transducer Array - White
- ITE Transducer Array Large White
- ITE Transducer Array Small Black
- ITE Transducer Array Small white
- NovoTAL flex
- Optune
- Optune HFE Transducer Array, black
- Optune HFE Transducer Array, white
- Torso Applicator
Showing 12 of 27 declared devices.
Catalogue references include ACM00012EU, IHEP9020BEU, IHEP9020WEU, ILE1010EU, ILE1030EU, INE9020W.
European nomenclature codes declared: Z12040285, Z12040299, Z12040282, Z12040280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOVOCURE GMBH (CH) · FDA 3010457505 |
| Devices in EUDAMED | 27 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 3.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOVOCURE GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2022-11-08 |
Licence types: System (1).
Licensed under: OPTUNE GIO.
North American profile: Both markets. Novocure GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1990188-1 | supplemented | 2027-03-23 |