Manufacturer registered with FDA
Forefront (Xiamen) Medical Devices Co., Ltd.
Xiamen, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 416 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Forefront (Xiamen) Medical Devices Co., 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 | Forefront (Xiamen) Medical Devices Co., Ltd. | 3 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Forefront (Xiamen) Medical Devices Co., Ltd.FOREFRONT (XIAMEN) MEDICAL DEVICES CO. LTD | 10 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FOREFRONT (XIAMEN) MEDICAL DEVICES CO. LTD.FOREFRONT (XIAMEN) MEDICAL DEVICES CO. LTD · FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD. | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Forefront (Xiamen) Medical Devices Co.,Ltd. | 1 | 2020–2020 | 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 Forefront (Xiamen) Medical Devices Co., 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 |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LED Adapter | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | — | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2019 |
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 |
|---|---|---|
| FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD.FDA reg. 3007695715 | Xiamen Fujian, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029104). 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.