Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013328880

FEI Number

3013328880

Entity Name

BONE INDEX FINLAND LTD.

City/State/Country

Kuopio Pohjois-Savo, FI

Establishment Address

Savilahdentie 14, Kuopio Pohjois-Savo 70700, FI

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Bone Index Finland Ltd. (Owner Number: 10052487)

Owner / Operator Contact Address

Savilahdentie 14, Kuopio, FI-15 70700, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211350

PMA Number

N/A

All Registered Proprietary Names

Bindex Measure BI-41 Bindex BI-2 Kit v1 (w/ Gel) Bindex BI-2 Kit v3 (w/o Gel) Bindex BI-2 Kit v2 (w/o Gel) Bindex BI-2 Kit v4 (w/o Gel) Bindex BI-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUA	Bone Sonometer	Radiology	Class 2	892.1180	2023-12-18

Official Correspondent

Janne Karjalainen

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Bone Index Finland 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
K161919	Cyberlogic, Inc.	UltraScan 650	2017-04-05

Similar Registrations

Registration Number	Establishment Name	Location
3005944888	CYBERLOGIC, INC.	Brooklyn, NY, US
3015973732	ECHOLIGHT S.P.A.	Lecce, IT
3006701790	BeamMed Ltd.	Petah Tikva Central, IL
9710602	GE MEDICAL SYSTEMS (CHINA) CO., LTD.	WUXI Jiangsu, CN
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013328880. Last updated year: 2026. Please use registration number 3013328880 when referencing this establishment in official correspondence.