Data / Medical devices / Ireland / Therakos Development Limited
Therakos Development Limited: FDA-registered device maker in Blanchardstown Dublin(County), Ireland, 1 PMA approval
Therakos Development Limited is registered with the FDA (registration 3036773437) in Blanchardstown Dublin(County), Ireland. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 8, 1987. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036773437
- Address
- Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Road North, Blanchardstown Dublin(County), Ireland, D15 AP2D
- Owner or operator
- Therakos Development Limited (10092738)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 12, 2025
- Registered through
- 2027
- Brand names listed
- THERAKOS CELLEX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Photopheresis, Extracorporeal | LNR | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 8, 1987 | P860003 | UVAR PHOTOPHERESIS SYSTEM | LNR | 107 | November 21, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 16, 2025 | 98558 | Class II | Ongoing | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (EC | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss. | accessdata.fda.gov |
Compare with other makers
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.