Manufacturer registered with FDA
Guangdong JINME Medical Technology Co., Ltd.
Foshan, China. Lists 10 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 16
- 510(k) clearances
- 52017–2026
- Markets registered in
- 1274 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Guangdong JINME 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 | Guangdong JINME Medical Technology Co., Ltd. | 5 clearances | 2017–2026 | Below |
| European Union | EUDAMED | Manufacturer | Guangdong JINME Medical Technology Co., Ltd. | 26 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guangdong JINME Medical Technology Co., Ltd. | 13 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTDGUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. | 9 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Guangdong Jinme Medical Technology Co., Ltd.Guangdong JINME Medical Technology Co.,Ltd. | 7 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. | 4 | 2020–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | GUANGDONG JINME MEDICAL TECHNOLOGY CO.LTDGuangdong JINME Medical Technology Co., Ltd. | 4 | 2020–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Guangdong JINME Medical Technology Co Ltd | 3 | 2021–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. | 2 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Guangdong JINME Medical Technology Co., Ltd.Guangdong Jinme Medical Technology Co.,Ltd | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Guangdong Jinme Medical Technology Co.,LTD | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTDGUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. | 2 | 2018–2019 | 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 Guangdong JINME 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 |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Dental High-Speed Turbine Handpiece (Model: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP)Dental Low-Speed Turbine Handpiece (Model: LN, L) | 2018 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Dental Low-Speed Turbine Handpiece (Model: LN, L) | 2018 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Surgical Drive System (model: ES70, ES90, E8)Surgical Drive System ES70 Kit (model: ES70 K1, ES70 K2)Surgical Drive System ES90 Kit (model: ES90 K1, ES90 K2, ES90 K3) | 2024 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Suction machine (model: suction 10, suction 20) | 2023 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Dental air compressor | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs | 2024 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intra Oral Scanner (Model: ECO-SCANNER 1, ECO-SCANNER 2) | 2023 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Air compressor (model: Air compressor)Testing machine (model: HP Tester) | 2023 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dental chair and accessories (Model: S600, S690, S610) | 2024 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | Intra Oral Camera (Model: ECO-CAMERA 01, ECO-CAMERA 02, ECO-CAMERA 03) | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Guangdong JINME Medical Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Oct 2026 | K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) | EIA Operative Dental Unit |
| 13 Nov 2024 | K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | EFB Dental Air-Powered Handpiece |
| 18 Jul 2024 | K240340 | Surgical Drive System (Model: ES70, ES90, E8) | DZI Powered Bone Drill |
| 21 Nov 2017 | K170236 | Dental Low-speed Turbine Handpiece | EFB Dental Air-Powered Handpiece |
| 8 Nov 2017 | K170229 | Dental High-speed Turbine Handpiece | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3012336822 | Foshan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051074). 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.