STEPHANIX
French manufacturer radiology medical imaging | Stephanix
French manufacturer radiology medical imaging | Stephanix
- Type
- Manufacturer
- Location
- La Ricamarie, France
- Founded
- 1985
- Website
- https://stephanix.fr
- Categories
- Medische en gezondheidszorgbenodigdheden
Listed in a source registry
France INSEE Sirene / INPI RNE state register (annuaire-entreprises.data.gouv.fr)
Verified facts
- lei-lapsed (amber), checked 2026-08-07 GLEIF global LEI register (golden copy)
- registry-active-global (green), checked 2026-08-07 France INSEE Sirene state register (data.gouv.fr bulk file)
- registered-manufacturer (green), checked 2026-08-07 France INSEE Sirene state register (data.gouv.fr bulk file)
- places-goods-on-market (green), checked 2026-08-09 Registre national des producteurs (ADEME/SYDEREP), France
- sanctions-clear (green), checked 2026-07-24 OpenSanctions
- vat-valid (green), checked 2026-07-24 VIES
- debarment-clear (green), checked 2026-07-24 OpenSanctions
- directors-on-file (green), checked 2026-07-24 INSEE Sirene (annuaire-entreprises)
- fda-registered (green), checked 2026-07-24 FDA
- media-mention (green), checked 2026-02-14 leprogres.fr
- export-registered (green), checked 2026-07-24 EU EORI validation (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)