Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042639792

FEI Number

3042639792

Entity Name

Unitron Medx LLC

City/State/Country

Cary, NC, US

Establishment Address

1941 Evans Rd, Cary, NC 27513, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Unitron Group (Owner Number: 10094335)

Owner / Operator Contact Address

Schansestraat 7, IJzendijke, NL-ZE 4515RN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POS	Physiological Signal Based Seizure Monitoring System	Neurology	Class 2	882.1580	2025-12-23

Official Correspondent

Nico Zeeders

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Unitron Group

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 3042639792. Last updated year: 2026. Please use registration number 3042639792 when referencing this establishment in official correspondence.