Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026023106

FEI Number

3026023106

Entity Name

EPINEURON TECHNOLOGIES INC.

City/State/Country

Mississauga Ontario, CA

Establishment Address

1875 Buckhorn Gate, Suite 602, Mississauga Ontario L4W 5P1, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Epineuron Technologies Inc. (Owner Number: 10087337)

Owner / Operator Contact Address

1875 Buckhorn Gate, Suite 602, Mississauga, CA-ON L4W 5P1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253536

PMA Number

N/A

All Registered Proprietary Names

Evala

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-02

Official Correspondent

Michael Willand

US Agent Details

Stephan Toupin Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Epineuron Technologies Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026023106. Last updated year: 2026. Please use registration number 3026023106 when referencing this establishment in official correspondence.