Manufacturer registered with FDA

Anji Hongde Medical Products Co Ltd

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

FDA owner/operator9083742Contract manufacturerForeign exporterManufacturer
Device types listed
1
Brands and models
3
510(k) clearances
0as applicant
Markets registered in
11123 registrations outside the US
Establishments
1China

Registered in 11 markets

Where regulators' registries name Anji Hongde Medical Products Co Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 43 registrationsSouth Korea: 22 registrationsEuropean Union: 19 registrationsBrazil: 10 registrationsTaiwan: 7 registrationsIsrael: 6 registrationsPeru: 6 registrationsAustralia: 5 registrationsTanzania: 4 registrationsSerbia: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAnji Hongde Medical Products Co Ltd1 device types—Below
ColombiaINVIMAManufacturerANJI HONGDE MEDICAL PRODUCTS CO., LTDANJI HONGDE MEDICAL PRODUCTS CO., LTD. · ANJI HONGDE MEDICAL PRODUCTS CO. LTD43—Pure Global AI
South KoreaMFDSManufacturerAnji Hongde Medical Products Co., LtdANJI HONGDE MEDICAL PRODUCTS CO., LTD. · ANJI HONGDE MEDICAL PRODUCTS CO.,LTD · +2222014–2026Pure Global AI
European UnionEUDAMEDManufacturerAnji Hongde Medical Products Co., Ltd19—Pure Global AI
BrazilANVISAManufacturerANJI HONGDE MEDICAL PRODUCTS CO., LTDAnji Hongde Medical Products CO. LTDA102020–2026Pure Global AI
TaiwanTFDAManufacturerANJI HONGDE MEDICAL PRODUCTS CO., LTD.72012–2024Pure Global AI
IsraelAMARManufacturerAnji Hongde Medical Products Co LtdANJI HONGDE MEDICAL PRODUCTS CO. LTD. · Anji Hongde Medical Products Co., Ltd.6—Pure Global AI
PeruDIGEMIDManufacturerANJI HONGDE MEDICAL PRODUCTS CO., LTD.62024–2026Pure Global AI
AustraliaTGAManufacturerAnji Hongde Medical Products Co Ltd52013–2025Pure Global AI
TanzaniaTMDAManufacturerAnji Hongde Medical Products Co. LtdANJI HONGDE MEDICAL PRODUCTS CO LTD42024–2026Pure Global AI
SerbiaALIMSManufacturerAnji Hongde Medical Products 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 Anji Hongde Medical Products 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 RollsDental Cotton rollsZigzag Cotton
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
ANJI HONGDE MEDICAL PRODUCTS CO., LTD.FDA reg. 3005621808HUZHOU Zhejiang, ChinaContract manufacturer, Foreign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9083742). 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.