Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036773437

FEI Number

3036773437

Entity Name

THERAKOS DEVELOPMENT LIMITED

City/State/Country

Blanchardstown Dublin, IE

Establishment Address

Suite 1 Plaza 211, Blanchardstown Corporate Park 2, Blanchardstown Road North, Blanchardstown Dublin D15 AP2D, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Therakos Development Limited (Owner Number: 10092738)

Owner / Operator Contact Address

Suite 1 Plaza 211, Blanchardstown Corporate Park 2,, Blanchardstown Road North, Blanchardstown, IE-D D15 AP2D, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P860003

All Registered Proprietary Names

THERAKOS CELLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNR	System, Photopheresis, Extracorporeal	Unknown	Class 3	N/A	2025-02-12

Official Correspondent

Erica Mullaney

US Agent Details

Brian Stimson Business: Therakos LLC Email: Brian.Stimson@therakos.com Phone: (585) 2335524

Related Public Records

Same Entity

Therakos Development Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036773437. Last updated year: 2026. Please use registration number 3036773437 when referencing this establishment in official correspondence.