Manufacturer registered with FDA
Keeler Ltd
WINDSOR, BERKSHIRE, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 14412 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 14 markets
Where regulators' registries name Keeler Ltd 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 | Keeler Ltd | 1 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Keeler Ltd. | 113 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Keeler Ltd.Keeler Ltd · KEELER LTD · +2 | 82 | 1998–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Keeler Ltd | 78 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | KEELER LIMITED | 28 | 2003–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KEELER LTD.Keeler Limited | 27 | 1991–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | KEELER LIMITEDKEELER LTD | 19 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Keeler Ltd | 18 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Keeler Ltd | 15 | 2004–2024 | Pure Global AI |
| China | NMPA | Registration holder | 睛乐有限责任公司Keeler Ltd | 9 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | KEELER LIMITED | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KEELER LTD. | 5 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Keeler LtdKEELER LTD. | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KEELER LIMITEDKEELER LTD | 5 | 2017–2026 | 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 Keeler Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | — | 2005 |
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 |
|---|---|---|
| KEELER LTD.FDA reg. 1000391004 | WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9011500). 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.