Manufacturer registered with FDA
Wenzhou Scico Medical Corporation Co.,Ltd.
Longgang City Wenzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 633 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Wenzhou Scico Medical Corporation 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 | Wenzhou Scico Medical Corporation Co.,Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Wenzhou Scico Medical Corporation Co., LtdWenzhou Scico Medical Corporation Co.,Ltd · (주)아리아크헬스케어^Wenzhou Scico Medical Corporation Co., Ltd · +2 | 15 | 2017–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WENZHOU SCICO MEDICAL CORPORATION CO. LTD | 8 | 2021–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Wenzhou Scico Medical Corporation Co.,Ltd | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Wenzhou Scico Medical Corporation Co., Ltd | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wenzhou Scico Medical Corporation Co Ltd | 2 | 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 Wenzhou Scico Medical Corporation 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 | — | Maker | Cotton RollCotton Swabs | 2017 |
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 Scico Medical Corporation Co.,Ltd.FDA reg. 3010957766 | Longgang, Wenzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046880). 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.