Registered with FDA

Suzhou Texnet

Suzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10057231Foreign exporter
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
472 registrations outside the US
Establishments
1China

Registered in 4 markets

Where regulators' registries name Suzhou Texnet as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedSouth Korea: 49 registrationsIsrael: 19 registrationsEuropean Union: 4 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerSuzhou Texnet1 device types—Below
South KoreaMFDSManufacturerSUZHOU TEXNET CO., LTD.SUZHOU TEXNET CO., LTD · Suzhou Texnet Co ., Ltd. · +2492013–2026Pure Global AI
IsraelAMARManufacturerSuzhou TexNet Co., LtdSuzhou TexNet Co. Ltd19—Pure Global AI
European UnionEUDAMEDManufacturerSuzhou Texnet Co.,Ltd4—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 Suzhou Texnet currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesLister
Suzhou Oral Brush
2025

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
SUZHOU TEXNETFDA reg. 3010339057Suzhou Jiangsu, ChinaForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10057231). 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.