Manufacturer registered with FDA
Yangzhou Royal Home Products Manufacture Co., Ltd.
Yangzhou, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Yangzhou Royal Home Products Manufacture 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 | Yangzhou Royal Home Products Manufacture Co., Ltd. | 9 device types | — | Below |
| Colombia | INVIMA | Manufacturer | YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTDYANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO. LTD | 3 | — | 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 Yangzhou Royal Home Products Manufacture 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirror, Mouth | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Wax, Dental, Intraoral | 2024 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Probe, Periodontic | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss, Dental | 2024 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Pick, Massaging | 2024 |
| Tongue ScraperLCN · Class 1 | — | Maker | Scraper, Tongue | 2024 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Eraser, Dental Stain | 2024 |
| Battery-Powered Ionic ToothbrushMMD · Class 1 | Toothbrushes | Maker | Toothbrush, Powered - Toothbrush, Powered - Electric Toothbrush; Toothbrush Head | 2024 |
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 |
|---|---|---|
| YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD.FDA reg. 3033918991 | Yangzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091930). 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.