SOPHYSA
Sophysa - Hydrocephalus Management and Neurocritical Care Monitoring
40+ years of experience serving customers worldwide through an international network of exclusive distributors
- Type
- Manufacturer
- Location
- Orsay, France
- Founded
- 1981
- Website
- https://sophysa.com
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
France INSEE Sirene / INPI RNE state register (annuaire-entreprises.data.gouv.fr)
Verified facts
- domain-registered (green), checked 2026-07-28 Domain registry record
- web-presence-since (green), checked 2026-08-19 Internet Archive (Wayback)
- insolvency-clear (green), checked 2026-08-20 BODACC (annuaire-entreprises)
- workforce-on-record (green), checked 2026-07-01 INSEE SIRENE (Registre national des entreprises)
- facility-registered (green), checked 2026-08-01 INSEE SIRENE (Registre national des entreprises)
- registered-since (green), checked 2026-08-01 INSEE SIRENE (Registre national des entreprises)
- bodacc-accounts-filed (green), checked 2026-08-20 BODACC (annuaire-entreprises)
- registry-change-published (green), checked 2026-08-20 BODACC (annuaire-entreprises)
- public-contract-awarded (green), checked 2024-10-24 TED (Tenders Electronic Daily), EU public procurement award notices Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- financials-published (green), checked 2024-12-31 INPI/BCE published accounts (data.economie.gouv.fr)
- registry-active-global (green), checked 2026-08-19 France INSEE Sirene state register (data.gouv.fr bulk file)
- registered-manufacturer (green), checked 2026-08-19 France INSEE Sirene state register (data.gouv.fr bulk file)
- export-registered (green), checked 2026-07-23 EU EORI validation (European Commission)
- directors-on-file (green), checked 2026-07-23 INSEE Sirene (annuaire-entreprises)
- vat-valid (green), checked 2026-07-31 VIES (European Commission)
- places-goods-on-market (green), checked 2026-08-16 Registre national des producteurs (ADEME/SYDEREP), France
- sanctions-clear (green), checked 2026-07-23 OpenSanctions
- debarment-clear (green), checked 2026-07-23 OpenSanctions
- media-mention (green), checked 2024-01-13 plus.besancon.fr
- fda-registered (green), checked 2026-07-23 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)