Manufacturer registered with FDA

Nantong Hope Industry & Trade Co., Ltd.

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

FDA owner/operator10048260Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
628 registrations outside the US
Establishments
1China

Registered in 6 markets

Where regulators' registries name Nantong Hope Industry & Trade Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 11 registrationsSouth Korea: 11 registrationsEuropean Union: 4 registrationsPeru: 1 registrationsTaiwan: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerNantong Hope Industry & Trade Co., Ltd.1 device types—Below
ColombiaINVIMAManufacturerNANTONG HOPE INDUSTRY & TRADE CO.,LTD11—Pure Global AI
South KoreaMFDSManufacturerNantong Hope Industry & Trade Co., Ltd.NANTONG HOPE INDUSTRY&TRADE CO., LTD. · Nantong Hope Industry & Trade Co., Ltd · +2112020–2026Pure Global AI
European UnionEUDAMEDManufacturerNantong Hope Industry & Trade Co., Ltd.4—Pure Global AI
PeruDIGEMIDManufacturerNANTONG HOPE INDUSTRY & TRADE CO. LTD.12026–2026Pure Global AI
TaiwanTFDAManufacturerNANTONG HOPE INDUSTRY & TRADE CO., LTD.12024–2024Pure 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 Nantong Hope Industry & Trade 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 BALL
2014

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
NANTONG HOPE INDUSTRY&TRADE CO.,LTD.FDA reg. 3011564291Rugao Jiangsu, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10048260). 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.