Manufacturer registered with FDA
Anji SPENQ Industrial Co., Ltd.
Huzhou, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6123 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Anji SPENQ Industrial 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 SPENQ Industrial Co., Ltd. | 4 device types | — | Below |
| Serbia | ALIMS | Manufacturer | Anji SPENQ Industrial Co., Ltd. | 52 | 2022–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ANJI SPENQ INDUSTRIAL CO., LTD.ANJI SPENQ INDUSTRIAL CO., LTD | 34 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Anji SPENQ Industrial Co., Ltd. | 31 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | ANJI SPENQ INDUSTRIAL CO. LTDAnji Spenq Industrial | 4 | 2022–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ANJI SPENQ INDUSTRIAL CO., LTD. | 2 | 2017–2022 | 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 SPENQ Industrial 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | SALIVA EJECTOR | 2022 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle | 2022 |
| Roll CottonEFN · Class 1 | — | Maker | Absorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball | 2022 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | DENTAL BIBS | 2022 |
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 SPENQ INDUSTRIAL CO., LTD.FDA reg. 3016758972 | Huzhou Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085700). 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.