Manufacturer registered with FDA
Jiangsu Rooe Medical Technology Co., Ltd.
Zhangjiagang City, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Jiangsu Rooe Medical Technology 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 Rooe Medical Technology Co., Ltd. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Jiangsu Rooe Medical Technology Co.,Ltd | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jiangsu Rooe Medical Technology Co., Ltd. | 1 | 2026–2026 | 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 Rooe Medical Technology 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | ROOE Electric Suction Unit; Manual Suction Unit; Sputum Suction Unit | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | ROOE Medical Dental Unit, Dental Accessories | 2024 |
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 ROOE MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3014739961 | Zhangjiagang City Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091569). 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.