Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680891

FEI Number

3006563303

Entity Name

MEGIN OY

City/State/Country

Espoo Uusimaa, FI

Establishment Address

Keilasatama 5, Espoo Uusimaa 02150, FI

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Megin Oy (Owner Number: 10058907)

Owner / Operator Contact Address

Keilasatama 5, Espoo, FI-18 02150, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233985

PMA Number

N/A

All Registered Proprietary Names

TRIUX neo Elekta Neuromag® TRIUX Elekta Neuromag® TRIUX (NM25000N) TRIUX neo (NM26000N) MEGreview MEG Maps TRIUX neo TRIUX neo (NM27000N)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Neurology	Class 2	882.1400	2018-11-08
OLY	Magnetoencephalograph	Neurology	Class 2	882.1400	2018-11-08
OLY	Magnetoencephalograph	Neurology	Class 2	882.1400	2024-05-21
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Neurology	Class 2	882.1400	2024-05-21

Official Correspondent

No official correspondent registered.

US Agent Details

Rick Goepfert Business: MEGIN US, LLC Email: rick.goepfert@megin.fi Phone: (703) 3624920

Related Public Records

Same Entity

Megin Oy

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 9680891. Last updated year: 2026. Please use registration number 9680891 when referencing this establishment in official correspondence.