Manufacturer registered with FDA
Zhejiang Risheng Medical Technology Co Ltd
Hangzhou, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 614 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Zhejiang Risheng Medical 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 | Zhejiang Risheng Medical Technology Co Ltd | 7 device types | — | Below |
| Australia | TGA | Manufacturer | Zhejiang Risheng Medical Technology Co Ltd | 5 | 2018–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Zhejiang Risheng Medical Technology Co.,Ltd | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Zhejiang Risheng Medical Technology Co ., LtdZhejiang Risheng Medical Technology Co., Ltd | 3 | 2024–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHEJIANG RISHENG MEDICAL TECHNOLOGY CO.,LTD | 1 | 2019–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Risheng Medical 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 Zhejiang Risheng 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | — | 2016 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2016 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Elastics including separator, power chain, O-ring, Elastic etc | 2019 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 2016 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2016 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | — | 2016 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Face Bow | 2022 |
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 |
|---|---|---|
| ZHEJIANG RISHENG MEDICAL TECHNOLOGY CO., LTDFDA reg. 3012715571 | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051577). 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.