E-Scopics
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000019303 FEI 3026405201
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What E-Scopics makes
E-Scopics manufactures ultrasound imaging systems, including the ES1 System, the ES Series V2, the Hepatoscope, and the e.C5-1 transducer.
The company is based in France, and its portfolio includes devices classified as Class II and Class IIa, which are listed in the EUDAMED database and the FDA 510(k) registry.
Catalogue
ES-Series Ref K260748
510(k) 510(k)ES1 System Ref K213102
510(k) 510(k)ES Series V2 Ref K232336
510(k) 510(k)Hepatoscope Ref 410_0001
CE MDR EUDAMEDGUDIDe.C5-1 Ref 210_0001
CE MDR 510(k) EUDAMEDGUDID
Company details
- EUDAMED SRN
- FR-MF-000019303
- FDA FEI number
- 3026405201
- DUNS number
- 280265015
- EU VAT number
- FR74841467293
- EUDAMED status
- Active
- EUDAMED registered name
- E-SCOPICS
- Registered address
- 235, Rue Léon Foucault, 13100, Aix-en-Provence, France
- Website
- www.e-scopics.com/
- [email protected]
- PRRC contact
- Aurelie Gruener
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Dec 2028
DNV Product Assurance AS 2460 1 certificate
- C542245 Issued
Quality management system EU MDR
- Issued
- 22 Dec 2023
- Expires
- 21 Dec 2028
Frequently asked questions
How many devices does E-SCOPICS have in the registry?
The registry currently lists 5 devices for E-SCOPICS. Devices recorded under merged duplicate company entries are counted once.
Which registries list E-SCOPICS's devices?
Among its 5 most recently registered devices, E-SCOPICS has devices listed in EUDAMED (2 devices), FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do E-SCOPICS's devices fall under?
Among its 5 most recently registered devices, the classes recorded for E-SCOPICS's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for E-SCOPICS?
EUDAMED lists 1 certificate for E-SCOPICS (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2023-12-22.
What are the newest devices from E-SCOPICS in the registry?
The most recently registered devices listed for E-SCOPICS include ES-Series, ES1 System, ES Series V2 and Hepatoscope.