Manufacturer registered with FDA

Foshan Safety Medical Equipment Co., Ltd.

China, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10090263Manufacturer1 clearance in five years
Device types listed
1
Brands and models
2
510(k) clearances
12024–2024
Markets registered in
43 registrations outside the US
Establishments
1China
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 4 markets

Where regulators' registries name Foshan Safety Medical Equipment Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedBrazil: 1 registrationsPeru: 1 registrationsTaiwan: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerFoshan Safety Medical Equipment Co., Ltd.1 clearances2024–2024Below
BrazilANVISAManufacturerFOSHAN SAFETY MEDICAL EQUIPMENT CO, LTD.12025–2025Pure Global AI
PeruDIGEMIDManufacturerFOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD.12026–2026Pure Global AI
TaiwanTFDAManufacturerFOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD.12022–2022Pure 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 Foshan Safety Medical Equipment Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
Dental Unit, Model: MareDental Unit, Model: Mare.1, Mare.2, Mare.3, Mare.4, Mare.5
2024

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Foshan Safety Medical Equipment Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
28 Feb 2024K231845Dental unit Model: MareEIA Operative Dental Unit

Registered establishments

EstablishmentLocationWhat it does
FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.FDA reg. 3013734432China Guangdong, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10090263). 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.