CorneaGen
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000028846 FEI 3005357288
CorneaGen is a medical device manufacturer based in the United States, with 48 devices listed in 4 registries (FDA Class I and III; EU Class IIa) as of 13 Nov 2026.
- Devices
- 48
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 46
- EUDAMED 1
- FDA 510(k) 1
- FDA PMA 1
- Device classes
- FDA Class I 46
- EU Class IIa 1
- FDA Class III 1
- Top EMDN categories
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000028846
- FDA FEI 3005357288
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
Search and filter all 48 devicesCompany details
- EUDAMED SRN
- US-MF-000028846
- FDA FEI number
- 3005357288
- EUDAMED status
- Active
- EUDAMED registered name
- CorneaGen
- Registered address
- 101, North Chestnut Street, 27101, Winston-Salem, United States
- Website
- www.CorneaGen.com
- PRRC contact
- Eleanor Brown
Frequently asked questions
How many devices does CorneaGen have in the registry?
The registry currently lists 48 devices for CorneaGen. Devices recorded under merged duplicate company entries are counted once.
Which registries list CorneaGen's devices?
Among its 48 most recently registered devices, CorneaGen has devices listed in EUDAMED (1 device), FDA 510(k) (1 device), FDA PMA (1 device) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CorneaGen's devices fall under?
Among its 48 most recently registered devices, the classes recorded for CorneaGen's devices are Class I, Class IIa and Class III. Each device page shows its own class and authorisation.
What are the newest devices from CorneaGen in the registry?
The most recently registered devices listed for CorneaGen include Coronet SLS-20-700, Coronet SLS-10-775, Coronet SLS-20-950 and Coronet SLS-10-900.