Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013246402

FEI Number

3013246402

Entity Name

MEDIRACER LTD.

City/State/Country

Oulu Kainuu, FI

Establishment Address

Kasarmintie 13, Oulu Kainuu 90130, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mediracer Ltd. (Owner Number: 10061237)

Owner / Operator Contact Address

Kasarmintie 13, Oulu, FI-14 90130, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190536

PMA Number

N/A

All Registered Proprietary Names

Mediracer NCS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2019-09-27
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2019-09-27

Official Correspondent

Katja Findlay

US Agent Details

Maria Makela Email: maria.makela@finntecpartners.com Phone: (201) 2944211

Related Public Records

Same Entity

Mediracer Ltd.

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 3013246402. Last updated year: 2026. Please use registration number 3013246402 when referencing this establishment in official correspondence.