Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000425315

FEI Number

1000425315

Entity Name

Bittium Biosignals Ltd.

City/State/Country

KUOPIO Pohjois-Savo, FI

Establishment Address

PIONEERINKATU 6, KUOPIO Pohjois-Savo 70800, FI

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bittium Biosignals Ltd. (Owner Number: 9027486)

Owner / Operator Contact Address

Pioneerinkatu 6, --, KUOPIO, FI-15 70800, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fast-Fix ECG Electrode BodyGuardian MINI Strip Bittium OmegaSnap 3-CH ECG Electrode Bittium OmegaSnap 1-CH ECG Electrode Bittium MiniSnap Sensitive 1-CH ECG Electrode Bittium OmegaSnap Multi-CH Adapter Bittium OmegaSnap 1-CH Adapter Bittium OmegaSnap 2-CH ECG Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-06-27

Official Correspondent

Aliina Nieminen

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Bittium Biosignals Ltd.

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

Similar Registrations

Registration Number	Establishment Name	Location
3013522941	JOHNSON MEDTECH LLC	Vandalia, OH, US
3013873578	SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD.	Shanghai, CN
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000425315. Last updated year: 2026. Please use registration number 1000425315 when referencing this establishment in official correspondence.