Manufacturer registered with FDA
Guilin Refine Medical Instrument Co., LTD.
Guilin, China. Lists 7 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 6
- 510(k) clearances
- 32023–2026
- Markets registered in
- 1184 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Guilin Refine 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 | Guilin Refine Medical Instrument Co., LTD. | 3 clearances | 2023–2026 | Below |
| European Union | EUDAMED | Manufacturer | Guilin Refine Medical Instrument Co.,Ltd. | 27 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guilin Refine Medical Instrument Co Ltd | 13 | 2020–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guilin Refine Medical Instrument Co Ltd | 11 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.GUILIN REFINE MEDICAL INSTRUMENT CO., LTD | 9 | 2024–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Guilin Refine Medical Instrument Co., Ltd. | 6 | 2023–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | GUILIN REFINE MEDICAL INSTRUMENT CO.,LTDGUILIN REFINE MEDICAL INSTRUMENT CO.,LTD. · Guilin Refine Medical Instrument Co., Ltd. | 6 | 2020–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | GUILIN REFINE MEDICAL INSTRUMENT CO., LTD | 5 | 2024–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUILIN REFINE MEDICAL INSTRUMENT Co., LTD. | 4 | 2019–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Guilin Refine Medical Instrument Co., Ltd. | 2 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Guilin Refine 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 Guilin Refine 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 | External Oral Aerosol Suction System | 2020 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Curing Light (Model: MaxCure9) | 2023 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Portable Dental X-ray Device (Model: GT-1) | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Dental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7 | 2022 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Gutta Percha Obturation System, MaxFill-G, MaxFill-P | 2022 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | — | 2024 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Ultrasonic Activator (Model: VAT-3) | 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 Guilin Refine Medical Instrument Co., LTD. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.FDA reg. 3016075921 | Guilin Guangxi, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10064688). 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.