Registered with FDA
Wenzhou Zhusi Medical Supplies Co., Ltd
Wenzhou City, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 522 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Wenzhou Zhusi Medical Supplies 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 | Lister | Wenzhou Zhusi Medical Supplies Co., Ltd | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Wenzhou Zhusi Medical Supplies Co., Ltd.Wenzhou Zhusi Medical Supplies Co.,Ltd · Wenzhou Zhusi Medical Supplies Co., Ltd · +2 | 18 | 2017–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Wenzhou Zhusi Medical Supplies Co.,Ltd. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wenzhou Zhusi Medical Supplies Co Ltd | 1 | 2022–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WENZHOU ZHUSI MEDICAL SUPPLIES CO. LTD. | 1 | 2021–2021 | 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 Wenzhou Zhusi Medical Supplies 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 |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Lister | Wenzhou Zhusi Medical Cotton Roll | 2020 |
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 |
|---|---|---|
| WENZHOU ZHUSI MEDICAL SUPPLIES CO., LTDFDA reg. 3017299525 | Wenzhou City Zhejiang, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076338). 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.