Manufacturer registered with FDA
Zumax Medical Co., Ltd.
SUZHOU, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 12026–2026
- Markets registered in
- 1092 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Zumax Medical 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 | Zumax Medical Co., Ltd. | 1 clearances | 2026–2026 | Below |
| South Korea | MFDS | Manufacturer | Zumax Medical Co., Ltd.Zumax Medical Co., Ltd · Zumax Medical Co.,Ltd. · +2 | 33 | 2009–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Zumax Medical CO., LTD. | 17 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zumax Medical Co Ltd | 12 | 2018–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZUMAX MEDICAL CO., LTD.ZUMAX MEDICAL CO, LTD. | 11 | 2011–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zumax Medical Co., LtdZUMAX MEDICAL CO, LTD · Zumax Medical CO., LTD · +2 | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZUMAX MEDICAL CO., LTD.Zumax Medical Co., Ltd | 6 | 2013–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZUMAX MEDICAL CO ., LTD.ZUMAX MEDICAL CO., LTD | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zumax Medical Co Ltd | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ZUMAX MEDICAL CO.LTD. | 1 | 2023–2023 | 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 Zumax Medical 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 |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | HEADLIGHTSHL8000 HEADLIGHTHL8200 HEADLIGHTHL8260 HEADLIGHTHL8300 HEADLIGHTHL8350 HEADLIGHT | 2006 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | DSD-01 Dental Suction Unit | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Micro Needle Holder | 2026 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | Broken Instrument Removal Kit | 2016 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | OMS2360 Surgical MicroscopeOMS2380 Surgical Microscope | 2026 |
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 |
|---|---|---|
| ZUMAX MEDICAL CO, LTD.FDA reg. 3006252153 | SUZHOU,JIANGSU, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9093892). 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.