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.

FDA owner/operator10046880Manufacturer
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.

All markets
United States: 1 device types listedSouth Korea: 15 registrationsBrazil: 8 registrationsEuropean Union: 4 registrationsUnited Kingdom: 4 registrationsAustralia: 2 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerWenzhou Scico Medical Corporation Co.,Ltd.1 device types—Below
South KoreaMFDSManufacturerWenzhou Scico Medical Corporation Co., LtdWenzhou Scico Medical Corporation Co.,Ltd · (주)아리아크헬스케어^Wenzhou Scico Medical Corporation Co., Ltd · +2152017–2026Pure Global AI
BrazilANVISAManufacturerWENZHOU SCICO MEDICAL CORPORATION CO. LTD82021–2024Pure Global AI
European UnionEUDAMEDManufacturerWenzhou Scico Medical Corporation Co.,Ltd4—Pure Global AI
United KingdomMHRAManufacturerWenzhou Scico Medical Corporation Co., Ltd4—Pure Global AI
AustraliaTGAManufacturerWenzhou Scico Medical Corporation Co Ltd22026–2026Pure 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 typeCategoryRoleBrands and modelsListed 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

EstablishmentLocationWhat it does
Wenzhou Scico Medical Corporation Co.,Ltd.FDA reg. 3010957766Longgang, Wenzhou Zhejiang, ChinaManufacturer

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.