Manufacturer registered with FDA
Changzhou Finno Medical Technology Co., Ltd.
Changzhou, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12025–2025
- Markets registered in
- 89 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Changzhou Finno Medical Technology 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 | Changzhou Finno Medical Technology Co., Ltd. | 1 clearances | 2025–2025 | Below |
| Peru | DIGEMID | Manufacturer | CHANGZHOU FINNO MEDICAL TECHNOLOGY CO., LTD. | 3 | 2014–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Changzhou Finno Medical Technology Co Ltd | 1 | 2026–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Changzhou Finno Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Changzhou Finno Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Changzhou Finno Medical Technology Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Changzhou Finno Medical Technology Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Changzhou Finno Medical Technology Co., Ltd. | 1 | — | 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 Changzhou Finno Medical Technology 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 |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Dental Cone-beam Computed Tomography (model: FinScan F350) | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Changzhou Finno Medical Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Jan 2025 | K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | OAS Dental Computed Tomography X-Ray |
Some of these clearances are listed with FDA today by another company: Changzhou Sifary Medical Technology Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHANGZHOU FINNO MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3035879459 | Changzhou Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092588). 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.