Sophysa
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000002870 FEI 3001587388
Sophysa is a medical device manufacturer based in France, with 151 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class III, I and IIa; FDA Class II) and 2 FDA recalls as of 12 Nov 2026.
- Devices
- 151
- Registrations
- EUDAMEDFDA
- FDA recalls
- 22 ongoing
Registry facts
- Registries
- EUDAMED 148
- FDA GUDID 66
- FDA 510(k) 3
- Device classes
- EU Class III 77
- EU Class I 62
- EU Class IIa 8
- FDA Class II 3
- EU Class IIb 1
- Top EMDN categories
- Encephalic and peripheral nervous system devices 78
- Instruments for functional explorations and therapeutic interventions 59
- Drainage and fluids collection devices 4
- Spinal medullar system devices 4
- Tubular devices 1
- Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis 1
- FDA recalls
- Identifiers
- EUDAMED SRN FR-MF-000002870
- FDA FEI 3001587388
- DUNS 262951353
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment, FDA recalls
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 devicesShowing 1-50 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.
Which registries list SOPHYSA's devices?
Among its 50 most recently registered devices, SOPHYSA has devices listed in EUDAMED (50 devices).
What risk classes do SOPHYSA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SOPHYSA's devices are Class I, Class IIa and Class III. Each device page shows its own class and authorisation.
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.
What are the newest devices from SOPHYSA in the registry?
The most recently registered devices listed for SOPHYSA include PRESSIO® 3 - PRODLUŽOVACÍ KABEL K MONITORU PACIENTA - 3 PARAMETRY (ICP, ICT, MAP), VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 80-400, PRESSIO® 3 - EXTENSION DE CÂBLE MONITEUR DE PATIENT - 3 PARAMÈTRES (PIC, TIC, PAM) and SOPHY® SM1-L VALVE / BURR HOLE RESERVOIR.