Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012094189

FEI Number

3012094189

Entity Name

BIOTEKNA SRL

City/State/Country

Marcon Veneto, IT

Establishment Address

Via Pialoi 39/4, Marcon Veneto 30020, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biotekna srl (Owner Number: 10093074)

Owner / Operator Contact Address

Via Pialoi 39/4, Marcon, IT-34 30020, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Performance Biotekna Biofeedback Performance Biotekna Body Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2025-03-27
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2025-03-27

Official Correspondent

Laura Lazzarini

US Agent Details

Francisco Cidral Email: cidral@scientificaconsulting.com Phone: (561) 4055059

Related Public Records

Same Entity

Biotekna srl

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012094189. Last updated year: 2026. Please use registration number 3012094189 when referencing this establishment in official correspondence.