Manufacturer registered with FDA
Carl Zeiss Meditec AG (Jena)
Jena, Germany. 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
- 1130 registrations outside the US
- Establishments
- 1China
Registered in 11 markets
Where regulators' registries name Carl Zeiss Meditec AG (Jena) 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 | Carl Zeiss Meditec AG (Jena) | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 6 | 2018–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Carl Zeiss (Meditec) Suzhou Co Ltd | 5 | 2016–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Carl Zeiss Meditec(Suzhou) Co., Ltd. | 5 | 1999–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CARL ZEISS MEDITEC (SUZHOU) CO., LTD. | 2 | 2016–2017 | Pure Global AI |
| Canada | Health Canada | Registration holder | CARL ZEISS MEDITEC (SUZHOU) CO., LTD. | 2 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Carl Zeiss Meditec (Suzhou ) Co., LtdCarl Zeiss Meditec (Suzhou) Co., Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 2 | 2023–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Carl Zeiss Meditec (Suzhou) Co., Ltd | 1 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CARL ZEISS MEDITEC (SUZHOU) CO., LTD | 1 | 2025–2025 | 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 Carl Zeiss Meditec AG (Jena) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | Fluorescence mode | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Carl Zeiss Meditec AG (Jena) lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Carl Zeiss Suzhou Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2018 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Carl Zeiss Meditec (Suzhou) Co., Ltd.FDA reg. 3032734659 | Suzhou Jiangsu, China | Manufacturer |
Other names on FDA records
Carl Zeiss Meditec (Suzhou) Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053564). 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.