Manufacturer registered with FDA
Carestream Healthcare International Company Limited
Shanghai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 888 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Carestream Healthcare International Company Limited 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 | Carestream Healthcare International Company Limited | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | CARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED | 62 | 2009–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Carestream Healthcare International Company Limited | 10 | 2009–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED | 8 | 2008–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Carestream Healthcare International Company Limited | 3 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Carestream Healthcare International Company Limited | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED | 2 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Carestream Healthcare International Company, Ltd | 1 | 2018–2018 | 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 Carestream Healthcare International Company Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | CS 1200CS 1500 | 2026 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | CS 7200; CS 7600; CS 7600 SCAN&GO DEVICE; CS 7600 SLOT PANEL | 2026 |
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 |
|---|---|---|
| Carestream Healthcare International Company, LtdFDA reg. 3004105475 | Shanghai, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095899). 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.