Manufacturer registered with FDA
Jiangsu Guangda Medical Material Group Co., Ltd.
Haian, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Jiangsu Guangda Medical Material Group 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 | Jiangsu Guangda Medical Material Group Co., Ltd. | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Jiangsu Guangda Medical Material Group Co Ltd | 2 | 2018–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Jiangsu Guangda Medical Material Group Co., Ltd. | 1 | — | 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 Jiangsu Guangda Medical Material Group 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 |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | Cotton Ball; Cotton Roll | 2008 |
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 |
|---|---|---|
| Jiangsu Guangda Medical Material Group Co., Ltd.FDA reg. 3006847952 | Haian Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023676). 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.