Ceramisys Ltd
Country not established FDA
- Devices
- 35
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Ceramisys Ltd makes
Ceramisys Ltd manufactures bioceramic orbital implants, such as the ORBTEX, designed for ocular reconstruction, and dental grafting materials under the REPROBONE brand for bone regeneration in oral surgery.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. Ceramisys Ltd is based in the United States.
Catalogue
Search and filter all 35 devicesCompany details
- DUNS number
- 423459374
FDA establishments
- Ceramisys Ltd Sheffield York · GB FEI 3007708799
Frequently asked questions
How many devices does CERAMISYS LTD have in the registry?
The registry currently lists 35 devices for CERAMISYS LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list CERAMISYS LTD's devices?
Among its 35 most recently registered devices, CERAMISYS LTD has devices listed in FDA 510(k) (2 devices) and FDA GUDID (33 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CERAMISYS LTD's devices fall under?
Among its 35 most recently registered devices, the classes recorded for CERAMISYS LTD's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from CERAMISYS LTD in the registry?
The most recently registered devices listed for CERAMISYS LTD include ReproBone RBD2.5, Orbtex Orbital Implant RPX18, ReproBone RBD5 and ReproBone RBM5.
Which FDA establishments are linked to CERAMISYS LTD?
1 FDA establishment is linked to CERAMISYS LTD in the registry; they are listed on the company page.