Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018070844

FEI Number

3018070844

Entity Name

BIONIT LABS S.R.L.

City/State/Country

Soleto Lecce, IT

Establishment Address

Via Cracovia, 1, Soleto Lecce 73010, IT

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BionIT Labs S.r.l. (Owner Number: 10080803)

Owner / Operator Contact Address

Via Cracovia, 1, Soleto, IT-LE 73010, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Myo Unit Wave Electrode Remote Wave Electrode Adam's Hand Adam's Skin ThunderCell Battery Adam's Hand - Trial/Loaner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCJ	Device, Skin Potential Measurement	Neurology	Class 2	882.1560	2024-01-22
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2025-01-07
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-01-07
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2026-03-18
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2026-03-18
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2021-02-26

Official Correspondent

Matteo Aventaggiato

US Agent Details

Christian Costantini Business: MACLIN POWER, INC. Email: sales@maclinmed.com Phone: (305) 5910181

Related Public Records

Same Entity

BionIT Labs S.r.l.

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
3017573591	SHANGHAI MAY SKIN INFORMATION TECHNOLOGY CO., LTD.	Shanghai, CN
3007084556	BEIJING ADSS DEVELOPMENT CO., LTD.	Beijing, CN
3043657394	BEIJING BEAUTEMAX TECHNOLOGY LIMITED	Beijing, CN
3017132875	BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.	Beijing, CN
3013397886	ADVANCE-ESTHETIC LLC	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018070844. Last updated year: 2026. Please use registration number 3018070844 when referencing this establishment in official correspondence.