Theia Holding SA
- Type
- Manufacturer
- Location
- La Chaux-de-Fonds Neuchatel, Switzerland
- Categories
- Dental Supplies & Equipment, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- places-goods-on-market (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- sanctions-clear (green), checked 2026-07-21 OpenSanctions
- registry-active-global (green), checked 2026-07-21 Zefix (Swiss commercial registry)
- fda-registered (green), checked 2026-07-21 FDA
- fda-contract-manufacturer (green), checked 2026-07-21 FDA
Claimed certifications
- FDA Registered FDA Establishment Registration
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)