Manufacturer registered with FDA
Robinson Healthcare Limited
Worksop, United Kingdom. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5187 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 5 markets
Where regulators' registries name Robinson Healthcare Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Robinson Healthcare Limited | 14 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Robinson Healthcare Ltd | 133 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Robinson Healthcare Ltd | 40 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Robinson Healthcare Limited | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Robinson Healthcare Ltd | 2 | 2025–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Robinson Healthcare Limited currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ROBINSON HEALTHCARE LIMITEDFDA reg. 3006410968 | Worksop Nottinghamshire, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062128). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.