Manufacturer registered with FDA
Anji Hongde Medical Products Co Ltd
Huzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- 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.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Anji Hongde Medical Products Co Ltd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ANJI HONGDE MEDICAL PRODUCTS CO., LTDANJI HONGDE MEDICAL PRODUCTS CO., LTD. · ANJI HONGDE MEDICAL PRODUCTS CO. LTD | 43 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Anji Hongde Medical Products Co., LtdANJI HONGDE MEDICAL PRODUCTS CO., LTD. · ANJI HONGDE MEDICAL PRODUCTS CO.,LTD · +2 | 22 | 2014–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Anji Hongde Medical Products Co., Ltd | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ANJI HONGDE MEDICAL PRODUCTS CO., LTDAnji Hongde Medical Products CO. LTDA | 10 | 2020–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ANJI HONGDE MEDICAL PRODUCTS CO., LTD. | 7 | 2012–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Anji Hongde Medical Products Co LtdANJI HONGDE MEDICAL PRODUCTS CO. LTD. · Anji Hongde Medical Products Co., Ltd. | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ANJI HONGDE MEDICAL PRODUCTS CO., LTD. | 6 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Anji Hongde Medical Products Co Ltd | 5 | 2013–2025 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Anji Hongde Medical Products Co. LtdANJI HONGDE MEDICAL PRODUCTS CO LTD | 4 | 2024–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Anji Hongde Medical Products Co., Ltd. | 1 | 2024–2024 | 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 Anji Hongde Medical Products Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed 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
| Establishment | Location | What it does |
|---|---|---|
| ANJI HONGDE MEDICAL PRODUCTS CO., LTD.FDA reg. 3005621808 | HUZHOU Zhejiang, China | Contract 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.