Data / Medical devices / France / Renishaw Mayfield
Renishaw Mayfield: FDA-registered device maker in Chassieu Rhone, France, 1 510(k) clearance
Renishaw Mayfield is registered with the FDA (registration 3009108888) in Chassieu Rhone, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 26, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009108888
- Address
- 31 rue Ampere, Chassieu Rhone, France, 69680
- Owner or operator
- Renishaw Mayfield (10047210)
- Roles
- Manufacturer
- First device listed
- December 5, 2024
- Registered through
- 2026
- Brand names listed
- Neuromate Framless Gen III
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2018 | K181706 | neuromate Gen III | HAW | Substantially Equivalent | Renishaw Mayfield Sarl | accessdata.fda.gov |
Compare with other makers
Updated July 26, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.