The Magstim Company Limited
GB-MF-000003956 · United Kingdom · Whitland, Carmarthenshire
The Magstim Company Limited is registered in the European database on medical devices as a manufacturer, with 76 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 62 |
|---|---|
| Class IIb | 14 |
Most frequent device types declared: 3010-00, 3020-00, 3021-00, 3526-00, 4185-00.
Among these devices, 47 are declared active, 2 with a measuring function.
Authorised representative in the Union: Technomed Europe.
Devices declared under this manufacturer
- Horizion MT Remote Coil
- Horizon 3.0 Break Control Foot Switch
- Horizon 3.0 Cart
- Horizon 3.0 Interface Unit
- Horizon 3.0 Non-Nav Coil Holder
- Horizon Power Supply Unit (PSU)
- Magstim 200² UI Controller
- Magstim 200² Stimulator
- Magstim BiStim² Controller
- Magstim TMS Patient Cap, Size M
- Magstim TMS Patient Cap, Size S
- Mast Extension,
Showing 12 of 76 declared devices.
Catalogue references include 3010-00, 3021-00, 4990-00, 5290-00, 5473-00, 5625-00.
European nomenclature codes declared: Z12101105, V9099, Z121002, Z120606, N018099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | THE MAGSTIM COMPANY LTD. (GB) · FDA 8021774 |
| Devices in EUDAMED | 76 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 76 |
|---|---|
| Found in the U.S. device database | 68 |
| Share | 89.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | THE MAGSTIM COMPANY LIMITED |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 2 |
| First licensed | 2005-11-22 |
Licence types: System (6).
Licensed under: MAGSTIM RAPID II SYSTEM (NERVE STIMULATOR), MAGSTIM MODEL 200 2, NEUROSIGN V4 INTRAOPERATIVE NERVE MONITOR, MAGSTIM HORIZON TMS THERAPY SYSTEM, HORIZON 3.0 TMS THERAPY SYSTEM, MAGSTIM GEODESIC (GES) 500 CLINICAL SYSTEM.
North American profile: Both markets. The Magstim Company Limited is registered in both the United States and Canada.