Registered with FDA
Anji Fangyuan Sanitary Material Co., Ltd.
ANJI, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 327 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Anji Fangyuan Sanitary Material 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 | Lister | Anji Fangyuan Sanitary Material Co., Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ANJI FANG YUAN SANITARY MATERIAL CO., LTD | 24 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Anji Fangyuan Sanitary Material Co., Ltd. | 3 | — | 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 Fangyuan Sanitary Material 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 | — | Lister | COTTON, ROLL | 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
| Establishment | Location | What it does |
|---|---|---|
| ANJI FANG YUAN SANITARY MATERIAL CO., LTD.FDA reg. 3007865243 | ANJI Zhejiang, China | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047042). 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.