Manufacturer registered with FDA
Guilin Veirun Medical Technology Co., Ltd.
Guilin, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 192
- 510(k) clearances
- 0as applicant
- Markets registered in
- 528 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Guilin Veirun Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Guilin Veirun Medical Technology Co., Ltd. | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | Guilin Veirun Medical Technology Co., LTDGuilin Veirun Medical Technology Co., Ltd. · Guilin Veirun Medical Technology Co.,Ltd · +2 | 13 | 2015–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Guilin Veirun Medical Technology Co.,Ltd. | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guilin Veirun Medical Technology Co Ltd | 5 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUILIN VEIRUN MEDICAL TECHNOLOGY CO., LTD | 2 | 2025–2026 | 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 Guilin Veirun 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Irrigation Device (Model: CX-H1) | 2024 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Endo Ultra Activator (Model: DA-1) | 2024 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Powder (Model: Classic, UKC-S2, UKG-S3) | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Ultrasonic Scaler TipsUltrasonic Scaler Tips E1Ultrasonic Scaler Tips E10Ultrasonic Scaler Tips E10DUltrasonic Scaler Tips E11Ultrasonic Scaler Tips E11DUltrasonic Scaler Tips E12DUltrasonic Scaler Tips E14Ultrasonic Scaler Tips E14DUltrasonic Scaler Tips E15 179 moreUltrasonic Scaler Tips E15DUltrasonic Scaler Tips E16Ultrasonic Scaler Tips E17Ultrasonic Scaler Tips E18Ultrasonic Scaler Tips E2Ultrasonic Scaler Tips E3Ultrasonic Scaler Tips E3DUltrasonic Scaler Tips E4Ultrasonic Scaler Tips E4DUltrasonic Scaler Tips E5Ultrasonic Scaler Tips E5DUltrasonic Scaler Tips E6Ultrasonic Scaler Tips E7Ultrasonic Scaler Tips ES3Ultrasonic Scaler Tips ES3DUltrasonic Scaler Tips ES4Ultrasonic Scaler Tips ES4DUltrasonic Scaler Tips ES5Ultrasonic Scaler Tips ES5DUltrasonic Scaler Tips G1Ultrasonic Scaler Tips G10Ultrasonic Scaler Tips G12Ultrasonic Scaler Tips G14Ultrasonic Scaler Tips G2Ultrasonic Scaler Tips G3Ultrasonic Scaler Tips G30Ultrasonic Scaler Tips G31Ultrasonic Scaler Tips G32Ultrasonic Scaler Tips G33Ultrasonic Scaler Tips G4Ultrasonic Scaler Tips G5Ultrasonic Scaler Tips G6Ultrasonic Scaler Tips G7Ultrasonic Scaler Tips G8Ultrasonic Scaler Tips G9Ultrasonic Scaler Tips GK1Ultrasonic Scaler Tips GK14Ultrasonic Scaler Tips GK16Ultrasonic Scaler Tips GK18Ultrasonic Scaler Tips GK2Ultrasonic Scaler Tips GK20Ultrasonic Scaler Tips GK21Ultrasonic Scaler Tips GK3Ultrasonic Scaler Tips GK4Ultrasonic Scaler Tips GK5Ultrasonic Scaler Tips GK6Ultrasonic Scaler Tips GK7Ultrasonic Scaler Tips GK8Ultrasonic Scaler Tips GS1Ultrasonic Scaler Tips GS2Ultrasonic Scaler Tips GS3Ultrasonic Scaler Tips GS4Ultrasonic Scaler Tips GS5Ultrasonic Scaler Tips GS6Ultrasonic Scaler Tips GS7Ultrasonic Scaler Tips GS8Ultrasonic Scaler Tips IM1Ultrasonic Scaler Tips IM2Ultrasonic Scaler Tips IM3Ultrasonic Scaler Tips IM4LUltrasonic Scaler Tips IM4RUltrasonic Scaler Tips P1Ultrasonic Scaler Tips P10Ultrasonic Scaler Tips P11Ultrasonic Scaler Tips P12Ultrasonic Scaler Tips P12LUltrasonic Scaler Tips P12RUltrasonic Scaler Tips P13LUltrasonic Scaler Tips P13RUltrasonic Scaler Tips P14LUltrasonic Scaler Tips P14RUltrasonic Scaler Tips P15Ultrasonic Scaler Tips P16Ultrasonic Scaler Tips P2LUltrasonic Scaler Tips P2LDUltrasonic Scaler Tips P2RUltrasonic Scaler Tips P2RDUltrasonic Scaler Tips P3Ultrasonic Scaler Tips P33Ultrasonic Scaler Tips P3DUltrasonic Scaler Tips P3LUltrasonic Scaler Tips P3RUltrasonic Scaler Tips P4Ultrasonic Scaler Tips P4DUltrasonic Scaler Tips P5Ultrasonic Scaler Tips P50LUltrasonic Scaler Tips P50RUltrasonic Scaler Tips P6Ultrasonic Scaler Tips P7Ultrasonic Scaler Tips P8Ultrasonic Scaler Tips PC60Ultrasonic Scaler Tips PC61Ultrasonic Scaler Tips PC62Ultrasonic Scaler Tips PS1Ultrasonic Scaler Tips PS3Ultrasonic Scaler Tips PS4Ultrasonic Scaler Tips S-E1Ultrasonic Scaler Tips S-E10Ultrasonic Scaler Tips S-E10DUltrasonic Scaler Tips S-E11Ultrasonic Scaler Tips S-E11DUltrasonic Scaler Tips S-E12DUltrasonic Scaler Tips S-E14Ultrasonic Scaler Tips S-E14DUltrasonic Scaler Tips S-E15Ultrasonic Scaler Tips S-E15DUltrasonic Scaler Tips S-E16Ultrasonic Scaler Tips S-E17Ultrasonic Scaler Tips S-E18Ultrasonic Scaler Tips S-E19DUltrasonic Scaler Tips S-E2Ultrasonic Scaler Tips S-E20DUltrasonic Scaler Tips S-E21LDUltrasonic Scaler Tips S-E21RDUltrasonic Scaler Tips S-E22DUltrasonic Scaler Tips S-E23DUltrasonic Scaler Tips S-E24DUltrasonic Scaler Tips S-E25LDUltrasonic Scaler Tips S-E25RDUltrasonic Scaler Tips S-E3Ultrasonic Scaler Tips S-E3DUltrasonic Scaler Tips S-E4Ultrasonic Scaler Tips S-E4DUltrasonic Scaler Tips S-E5Ultrasonic Scaler Tips S-E5DUltrasonic Scaler Tips S-E6Ultrasonic Scaler Tips S-E7Ultrasonic Scaler Tips S-G1Ultrasonic Scaler Tips S-G10Ultrasonic Scaler Tips S-G14Ultrasonic Scaler Tips S-G2Ultrasonic Scaler Tips S-G3Ultrasonic Scaler Tips S-G30Ultrasonic Scaler Tips S-G31Ultrasonic Scaler Tips S-G32Ultrasonic Scaler Tips S-G33Ultrasonic Scaler Tips S-G4Ultrasonic Scaler Tips S-G5Ultrasonic Scaler Tips S-G6Ultrasonic Scaler Tips S-G7 | 2026 |
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 |
|---|---|---|
| GUILIN VEIRUN MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3011463882 | Guilin Guangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092327). 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.