SIRONA DENTAL SYSTEMS GMBH
- Type
- Manufacturer
- Location
- BENSHEIM Hesse, Germany
- Categories
- 医疗保健用品
Listed in a source registry
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- facility-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
- export-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
- aeo-certified (green), checked 2026-08-07 EU AEO register (European Commission)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)