Epiminder America Inc

FDA Device Registration & Listing · Irving, TX, US · Registration 3039640505

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3039640505
FEI Number
3039640505
Entity Name
Epiminder America Inc
City/State/Country
Irving, TX, US
Establishment Address
4545 Fuller Dr Ste 225, Irving, TX 75038, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Epiminder Limited (Owner Number: 10093773)
Owner / Operator Contact Address
525 Collins Street, West Podium, Mezzanine 2, Office 210/211, Melbourne, AU-VIC 3000, AU
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
DEN240062
PMA Number
N/A

All Registered Proprietary Names

Minder

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring Neurology Class 2 882.1360 2025-07-08

Official Correspondent

Tracy Cameron

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Epiminder Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3039411139 EPIMINDER LIMITED Melbourne Victoria, AU

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039640505. Last updated year: 2026. Please use registration number 3039640505 when referencing this establishment in official correspondence.
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