Manufacturer registered with FDA

Danyang Sunmed Healthcare Corporation

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

FDA owner/operator10029530Foreign exporterManufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
538 registrations outside the US
Establishments
1China

Registered in 5 markets

Where regulators' registries name Danyang Sunmed Healthcare Corporation as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 20 registrationsUnited Kingdom: 12 registrationsAustralia: 3 registrationsBrazil: 3 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDanyang Sunmed Healthcare Corporation1 device types—Below
European UnionEUDAMEDRegistration holderDanyang Sunmed Healthcare CorporationDANYANG SUNMED HEALTHCARE CORPORATION20—Pure Global AI
United KingdomMHRAManufacturerDanyang Sunmed Healthcare Corporation12—Pure Global AI
AustraliaTGAManufacturerDanyang Sunmed Healthcare Corporation32013–2026Pure Global AI
BrazilANVISAManufacturerDANYANG SUNMED HEALTHCARE CORPORATION32016–2026Pure 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 Danyang Sunmed Healthcare Corporation currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesMaker
tooth brush
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
DANYANG SUNMED HEALTHCARE CORPORATIONFDA reg. 3007649424Danyang Jiangsu, ChinaForeign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029530). 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.