Sopro
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000000833 FEI 3004084693
Sopro is a medical device manufacturer based in France, with 241 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa and I) as of 13 Nov 2026.
- Devices
- 241
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 134
- EUDAMED 97
- FDA 510(k) 23
- Device classes
- FDA Class II 141
- EU Class IIa 53
- EU Class I 43
- FDA Class I 4
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000000833
- FDA FEI 3004084693
- DUNS 264205501
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Sopro makes
SOPRO manufactures diagnostic-imaging multiformat cameras, dental digital imaging sensors for intraoral use, laparoscopic insufflators, endoscopic light source units, endoscope video cameras, dental computed radiography digital imaging scanners, and endoscopic irrigation/aspiration pumps.
These devices are classified as Class I, Class II, and Class IIa and are listed in Eudamed, FDA 510(k), and FDA UDI registries. The company is based in France.
Catalogue
Search and filter all 241 devicesShowing 1-50 of 241
Company details
- EUDAMED SRN
- FR-MF-000000833
- FDA FEI number
- 3004084693
- DUNS number
- 264205501
- EU VAT number
- FR52310558770
- EUDAMED status
- Active
- EUDAMED registered name
- SOPRO
- Registered address
- Avenue des Genévriers, 13705, La Ciotat, France
- Website
- www.acteongroup.com
- Phone
- +33 4 42 98 01 01
- PRRC contact
- Kim Rouahi
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 26 Dec 2027
GMED SAS 0459 1 certificate
- 39219 Restricted
Quality management system EU MDR
- Issued
- 12 Jun 2026
- Expires
- 26 Dec 2027
- Reason
- Not on market
Frequently asked questions
How many devices does SOPRO have in the registry?
The registry currently lists 241 devices for SOPRO. Devices recorded under merged duplicate company entries are counted once.
Which registries list SOPRO's devices?
Among its 50 most recently registered devices, SOPRO has devices listed in EUDAMED (4 devices), FDA 510(k) (1 device) and FDA GUDID (45 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SOPRO's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SOPRO's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SOPRO?
EUDAMED lists 1 certificate for SOPRO (quality management system) under MDR. The most recent was issued on 12 Jun 2026.
What are the newest devices from SOPRO in the registry?
The most recently registered devices listed for SOPRO include SOPIX2, SOPIX 2, SOPIX and PSPIX2.