Registered with FDA
Siemens Healthineers AG
Erlangen, 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
- 13332 registrations outside the US
- Establishments
- 1Germany
Registered in 13 markets
Where regulators' registries name Siemens Healthineers AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Siemens Healthineers AG | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Siemens Healthineers AGSiemens Healthineers Ltd. · Siemens Healthineers Ltd · +1 | 129 | 2002–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Siemens Healthineers AGSIEMENS HEALTHINEERS LTD. · Siemens Healthineers Ltd. | 84 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SIEMENS HEALTHINEERS AG | 34 | 2013–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Siemens Healthineers AG | 21 | 2016–2024 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Siemens Healthineers AG | 13 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Siemens Healthineers AG | 13 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SIEMENS HEALTHINEERS AG | 11 | 2020–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Siemens Healthineers AG | 10 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Siemens Healthineers AG | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SIEMENS HEALTHINEERS AG | 6 | 2017–2026 | Pure Global AI |
| China | NMPA | Registration holder | 西门子医疗股份公司Siemens Healthineers AG | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Siemens Healthineers AG | 1 | 2026–2026 | 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 Siemens Healthineers AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Kenex Mobile Cassett Holder | 2018 |
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 |
|---|---|---|
| Siemens Healthineers AGFDA reg. 3004977335 | FORCHHEIM Bavaria, Germany | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010024). 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.