Sophysa
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000002870 FEI 3001587388
- Devices
- 151
- Registrations
- EUDAMEDFDA
- FDA recalls
- 22 ongoing
What Sophysa makes
Sophysa manufactures general-purpose pneumatic suction systems, adjustable valves for cerebrospinal fluid management, and burr hole reservoirs. Their product portfolio also includes catheter passers, locating instruments, and various patient monitor cables for blood pressure and temperature measurement.
The company is based in France, and its devices are categorized under Class I, Class II, Class III, Class IIa, and Class IIb. These products are listed in the EUDAMED database and have received FDA 510(k) clearance.
Catalogue
Search and filter all 151 devices- Regimes: CE MDD Registry: EUDAMEDGUDID
Showing 151-151 of 151
Company details
- EUDAMED SRN
- FR-MF-000002870
- SRN (system / procedure pack)
- FR-PR-000038440
- FDA FEI number
- 3001587388
- DUNS number
- 262951353
- EU VAT number
- FR06306979584
- EUDAMED status
- Active
- EUDAMED registered name
- SOPHYSA
- Registered address
- 5, GUY MOQUET, 91400, ORSAY, France
- Website
- www.sophysa.fr
- contact@sophysa.fr
- Phone
- +33169351055
- PRRC contact
- JULIE LOPEZ
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 5 Mar 2030
GMED SAS 0459 2 certificates
- 40615 Active
Quality management system EU MDR
- Issued
- 28 Aug 2026
- Expires
- 27 Aug 2031
- 40171 Active
Quality management system EU MDR
- Issued
- 3 Aug 2026
- Expires
- 5 Mar 2030
- Reason
- Add device or group
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 9 Apr 2024 Z-1825-2024 Class II Ongoing An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Full distribution text
- 9 Apr 2024 Z-1826-2024 Class II Ongoing An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Full distribution text
- 9 Apr 2024 Z-1825-2024 Class II Ongoing An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
FDA establishments
- Sophysa SA US
Frequently asked questions
How many devices does SOPHYSA have in the registry?
The registry currently lists 151 devices for SOPHYSA. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for SOPHYSA?
FDA recall records list 2 recalls initiated by SOPHYSA, the most recent initiated on 9 Apr 2024. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for SOPHYSA?
EUDAMED lists 2 certificates for SOPHYSA (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 28 Aug 2026.
Which FDA establishments are linked to SOPHYSA?
1 FDA establishment is linked to SOPHYSA in the registry; they are listed on the company page.