Renishaw Mayfield SARL
FR-MF-000000506 · France · Chassieu
Renishaw Mayfield SARL is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 48 |
|---|---|
| Class IIb | 7 |
Among these devices, 17 are declared active.
Devices declared under this manufacturer
- neuroinspire PC – Desktop
- neuroinspire SW Atlas module
- neuroinspire neuroendoscopic module
- neuroinspire neurolocate 3D module
- neuromate - Tool guide OD30 - Introduction guide for specific shape of
- neuromate - Tool guide OD30 - Storz endoscope 28162BS
- neuromate - Tool guide OD30 - Storz endoscope 28164LLS (Little Lotta)
- neuromate - Tool guide OD30 - for standard guide
- neuromate Fischer ZD frame attachment - clamp
- neuromate Fischer ZD frame attachment - kit 10° angle
- neuromate Fischer ZD frame attachment - support
- neuromate Leksell frame attachment
Showing 12 of 55 declared devices.
Catalogue references include 001.0124, 001.0131, 001.0142, 003.0136, 003.0140, 003.0159.
European nomenclature codes declared: Z12100680, Z12100682, Z12100692, Z12100601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RENISHAW MAYFIELD (FR) · FDA 3009108888 |
| Devices in EUDAMED | 55 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 55 |
|---|---|
| Found in the U.S. device database | 23 |
| Share | 41.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RENISHAW MAYFIELD SARL |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2016-08-04 |
Licence types: Single Device (1).
Licensed under: NEURO|MATE STEREOTACTIC SYSTEM.
North American profile: Both markets. Renishaw Mayfield SARL is registered in both the United States and Canada.