Manufacturer registered with FDA
Hangzhou Rollmed Co.,Ltd.
Hangzhou, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 551 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Hangzhou Rollmed 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 | Hangzhou Rollmed Co.,Ltd. | 5 device types | — | Below |
| Brazil | ANVISA | Manufacturer | HANGZHOU ROLLMED CO.,LTDHANGZHOU ROLLMED CO., LTD | 21 | 2017–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HANGZHOU ROLLMED CO., LTD | 15 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hangzhou Rollmed co ., LTDHANGZHOU ROLLMED CO.,LTD · Hangzhou Rollmed Co., Ltd · +2 | 14 | 2019–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Hangzhou Rollmed Co Ltd | 1 | 2026–2026 | 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 Hangzhou Rollmed 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | saliva ejector | 2017 |
| Roll CottonEFN · Class 1 | — | Maker | ROLLMED | 2016 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | STRIP CAP | 2021 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | scale | 2017 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Cdental floss pick | 2025 |
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 |
|---|---|---|
| HANGZHOU ROLLMED CO.,LTD.FDA reg. 3013530901 | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053608). 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.