Manufacturer registered with FDA
Huizhou Gold Rose Technology Co.,Ltd
HUIZHOU, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Huizhou Gold Rose 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 | Huizhou Gold Rose Technology Co.,Ltd | 7 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Huizhou Gold Rose Technology 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 Huizhou Gold Rose 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 |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Brace | 2023 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | M11Oral Red Light Massager | 2025 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | water flosserWF100WF200WF300 | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | BA-8008electric toothbrushZ1TZ7T | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | dental floss electricThe Electric Dental FlosserZ2,Z8,Z9,Z10,Z11,Z12,Z13,Z14Z3,Z1,Z4,Z5,Z6,Z7,Z15 | 2024 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | — | 2026 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Teeth Whitening Kit | 2021 |
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 |
|---|---|---|
| HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTDFDA reg. 3017618900 | huizhou Guangdong, China | Complaint file establishment, Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078391). 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.