SEPTODONT
- Type
- Manufacturer
- Location
- CEDEX Val-de-Marne, France
- Categories
- Dental Supplies & Equipment
Listed in a source registry
Verified facts
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- facility-registered (green), checked 2026-08-17 US FDA device establishment registration (openFDA)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- places-goods-on-market (green), checked 2026-08-07 Finnish Medicines Agency (Fimea), basic register of medicinal products
- debarment-clear (green), checked 2026-08-20 OpenSanctions
- sanctions-clear (green), checked 2026-08-20 OpenSanctions
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)