Not currently registered with FDA under this name
Carl Zeiss Suzhou Co., Ltd.
Suzhou, China. Named as applicant on 1 dental 510(k) clearance between 2018 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12018–2018
- Markets registered in
- 1035 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Carl Zeiss Suzhou 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 | Applicant | Carl Zeiss Suzhou Co., Ltd. | 1 clearances | 2018–2018 | Below |
| Saudi Arabia | SFDA | Manufacturer | Carl Zeiss Suzhou Co., LtdCarl Zeiss Suzhou Co.,Ltd | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CARL ZEISS SUZHOU CO., LTD. | 7 | 2011–2021 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Carl Zeiss Suzhou Co., Ltd. | 6 | 2024–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Carl Zeiss Suzhou Co., Ltd | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Carl Zeiss Suzhou Co., Ltd. | 3 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Carl Zeiss Suzhou Co. LtdCarl Zeiss Suzhou Co., Ltd | 2 | 2023–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Carl Zeiss Suzhou Co.,Ltd. | 1 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Carl Zeiss Suzhou Co., Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Carl Zeiss Suzhou Co., Ltd | 1 | 2016–2016 | 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
510(k) clearances
Clearances on which FDA names Carl Zeiss Suzhou Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 May 2018 | K171007 | Fluorescence Mode | NBL Light-Induced Fluorescence Caries Detector |
Some of these clearances are listed with FDA today by another company: Carl Zeiss Meditec AG (Jena) (1).
Sources
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 of the most recent filing, which can be a US agent.