Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022175264

FEI Number

3022175264

Entity Name

NEURO EVENT LABS OY

City/State/Country

Tampere Pirkanmaa, FI

Establishment Address

Biokatu 10, Tampere Pirkanmaa 33520, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neuro Event Labs Oy (Owner Number: 10094789)

Owner / Operator Contact Address

Biokatu 10, Tampere, FI-11 33520, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251506

PMA Number

N/A

All Registered Proprietary Names

Nelli

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

Pierre Pelletier

US Agent Details

Danny West Business: FDA Agent Pro LLC Email: dwest@fdaagentpro.com Phone: (619) 4103383

Related Public Records

Same Entity

Neuro Event Labs Oy

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3012933969	EMPATICA S.r.l.	Milano, IT
3043349255	EpiWatch, Inc.	Baltimore, MD, US
3014886121	INTOPS CO.,LTD.	Suwon Gyeonggi, KR
3042639792	Unitron Medx LLC	Cary, NC, US
3017084392	LIVASSURED	Leiden Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022175264. Last updated year: 2026. Please use registration number 3022175264 when referencing this establishment in official correspondence.