Manufacturer registered with FDA
medmix China LTD
Shanghai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name medmix China 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 | medmix China LTD | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | medmix China LTD | 1 | 2025–2025 | 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 medmix China 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 Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Components Dispenser 25ml,1:1Dispenser 25ml 1:1/2:1Dispenser 50ml 1:1/2:1Dispenser, 25ml, 1:1Dispenser, 25ml, 1:1/2:1, printedDispenser, 50ml, 1:1Dispenser, 5ml, 1:1Dispenser,5ml,1:1 | 2022 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dispenser 50ml 1:1/2:1 | 2020 |
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 |
|---|---|---|
| medmix China LTDFDA reg. 3016654925 | Shanghai, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10063063). 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.