Manufacturer registered with FDA
Zhejiang Shinye Medical Technology Corp.,Ltd
Gongshu District, Hangzhou, China. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9497 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Zhejiang Shinye Medical Technology Corp.,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 Shinye Medical Technology Corp.,Ltd | 10 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zhejiang Shinye Medical Technology Corp. , Ltd. | 461 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Zhejiang Shinye Medical Technology Corp.,Ltd | 16 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zhejiang Shinye Medical Technology Corp., Ltd.ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD · ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD. | 6 | 2011–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Zhejiang Shinye Medical Technology Corp.,Ltd.Zhejiang Shinye Medical Technology Corp., Ltd. · Zhejiang Shinye Medical Technology Corp., Ltd.. | 5 | 2015–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD | 3 | 2015–2015 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Zhejiang Shinye Medical Technology Corp., Ltd | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Shinye Medical Technology Corp LtdZhejiang Shinye Medical Technology Corp., Ltd. | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP.,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 Shinye Medical Technology Corp.,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 | RETAINERSCREW EXPANSION | 2002 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | WIRE | 2002 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | TUBE | 2002 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | BAND | 2002 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CLAMP | 2002 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | SPRING | 2002 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | LIGATURE TUCKING | 2002 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | BAND | 2002 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | BRACKET | 2002 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Plier | 2002 |
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 Shinye Medical Technology Corp.,LtdFDA reg. 3003850991 | HANGZHOU Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053329). 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.