Manufacturer registered with FDA
Nanning Baolai Medical Instrument Co., Ltd.
NANNING, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 10
- 510(k) clearances
- 12015–2015
- Markets registered in
- 920 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Nanning Baolai Medical Instrument 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 | Nanning Baolai Medical Instrument Co., Ltd. | 1 clearances | 2015–2015 | Below |
| Australia | TGA | Manufacturer | Nanning Baolai Medical Instrument Co Ltd | 8 | 2010–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTDNANNING BAOLAI MEDICAL INSTRUMENT CO.,LTD · NANNING BAOLAI MEDICALINSTRUMENT CO.,LTD · +1 | 5 | 2010–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NANNING BAOLAI MEDICAL INSTRUMENT CO. LTD.NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD | 2 | 2013–2017 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NANNING BAOLAI MEDICAL INSTRUMENT CO. LTD. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. | 1 | 2024–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Nanning Baolai Medical Instrument Co., LTD. | 1 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Nanning Baolai Medical Instrument 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 Nanning Baolai Medical Instrument 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 | Extraoral suction system model: ESS1 | 2020 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | BD2CD1; CD2 ;CD3GL5,GL5LK10P8L,MPT1P9-2P9-3RH1,RHS,RH2,RH3,RL1,RL3,RD1,RD2,RD3,RP1,RP2,RP3,RP4,RP5Ultrasonic Scaler, P7,B5,B5S,B5L,P4,P5,P5L,B6,B6S,B6L,P6,P7L,P9,P9L,C5,C5S,C5L,C6,C7,C7L | 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 |
|---|---|---|
| NANNING BAOLAI MEDICAL INSTRUMENT CO., LTDFDA reg. 3008615394 | NANNING Guangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049130). 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.