THERAKOS, INC.
FDA registration: United States Last updated 27 May 2026
- Devices
- 12
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Cellex Clxusa Ref CLXUSA
Cellex Clxsp-U Ref CLXSP-U
Cellex Clxlgt Ref CLXLGT
Cellex Clxusa Ref CLXUSA
Cellex Cellexusa Ref CELLEXUSA
Cellex Clxsp-I Ref CLXSP-I
Uvar Xts Ref UVAR XTS
Uvar Xts XT20 Ref XT20
Cellex Clxcc-U Ref CLXCC-U
Uvar Xts XT125 Ref XT125
Uvar Xts XT001 Ref XT001
Cellex Clxcc-I Ref CLXCC-I
What THERAKOS, INC. makes
Therakos, Inc. manufactures photopheresis systems, including blood sets, system units, and lamp assemblies designed for extracorporeal photopheresis (ECP) therapy. These devices are used to treat conditions such as cutaneous T-cell lymphoma and graft-versus-host disease by exposing a patient’s blood to ultraviolet light and returning it to circulation. The primary product, the CELLEX system, integrates these components into a single therapeutic platform.
The company’s devices are classified as Class III under FDA regulations, requiring premarket approval (PMA) due to their high-risk nature. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates within the United States, adhering to domestic regulatory standards for these authorised systems.
Frequently asked questions
How many devices does THERAKOS, INC. have in the registry?
The registry currently lists 12 devices for THERAKOS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list THERAKOS, INC.'s devices?
Among its 12 most recently registered devices, THERAKOS, INC. has devices listed in EUDAMED (5 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do THERAKOS, INC.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for THERAKOS, INC.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from THERAKOS, INC. in the registry?
The most recently registered devices listed for THERAKOS, INC. include CELLEX CLXUSA, CELLEX CLXSP-U, CELLEX CLXLGT and CELLEX CELLEXUSA.
Information
- FDA registration
- United States
- Website
- therakos.com
- [email protected]
- Phone
- +1(855)422-9115
- DUNS number
- 003083703