Sonio
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000018467 FEI 3029937167
Sonio is a medical device manufacturer based in France, with 7 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class I and II) as of 13 Nov 2026.
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 5
- EUDAMED 3
- FDA 510(k) 2
- Device classes
- EU Class IIa 3
- FDA Class I 2
- FDA Class II 2
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000018467
- FDA FEI 3029937167
- DUNS 274345745
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Sonio makes
Sonio develops medical image management systems, including software solutions like the Sonio Pro (v3 and original), Sonio Detect (v3 and original), and Sonio Suspect, designed for processing and analyzing ultrasound images.
The company’s portfolio includes devices classified as Class I, Class II, and Class IIa, with registrations in the EU via eudamed, FDA 510(k) clearances in the US, and FDA UDI listings. The company is based in France.
Catalogue
Sonio Suspect Ref K261519
Regimes: 510(k) Registry: 510(k)- Registry: GUDID
- Registry: GUDID
Sonio Detect (v3) Ref K252433
Regimes: CE MDR 510(k) Registry: 510(k)Sonio Detect Ref v2
Regimes: CE MDR Registry: EUDAMEDGUDIDSonio Suspect Ref v1
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDIDSonio Detect Ref v1
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- FR-MF-000018467
- FDA FEI number
- 3029937167
- DUNS number
- 274345745
- EU VAT number
- FR30883053571
- EUDAMED status
- Active
- EUDAMED registered name
- Sonio
- Registered address
- 147, rue d'Aboukir, 75002, Paris, France
- Website
- sonio.ai/en/
- PRRC contact
- Florian Akpakpa
Frequently asked questions
How many devices does SONIO have in the registry?
The registry currently lists 7 devices for SONIO. Devices recorded under merged duplicate company entries are counted once.
Which registries list SONIO's devices?
Among its 7 most recently registered devices, SONIO has devices listed in EUDAMED (3 devices), FDA 510(k) (2 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SONIO's devices fall under?
Among its 7 most recently registered devices, the classes recorded for SONIO's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from SONIO in the registry?
The most recently registered devices listed for SONIO include Sonio Suspect, Sonio Pro v3, Sonio Pro 2 and Sonio Detect (v3).