Manufacturer registered with FDA
Jiangsu Keling Medical Appliances Co.,Ltd.
Yangzhou, 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
- 621 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Jiangsu Keling Medical Appliances 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 Keling Medical Appliances Co.,Ltd. | 1 device types | — | Below |
| Tanzania | TMDA | Manufacturer | Jiangsu Keling Medical Appliances CO., Ltd | 13 | 2023–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JIANGSU KELING MEDICAL APPLIANCES CO., LTD. | 3 | 2026–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Jiangsu Keling Medical Appliances Co., Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jiangsu Keling Medical Appliances Co., Ltd.Jiangsu Keling Medical Appliances Co.,Ltd. | 2 | 2007–2007 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jiangsu Keling Medical Appliances Co., Ltd. | 1 | 2018–2018 | 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 Keling Medical Appliances 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 | operation light(Model:KL-LED.STR78 series, KL-LED.DTR78 series KL-LED.D78 series, KL-LED.STZ4 series, KL-LED.STZ5series) | 2015 |
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 KELING MEDICAL APPLIANCES CO.,LTD.FDA reg. 3010373530 | Yangzhou Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050477). 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.