Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016432796

FEI Number

3016432796

Entity Name

MB Elettronica S.r.l.

City/State/Country

Cortona Arezzo, IT

Establishment Address

Zona Ind.le C.S. Ossaia, 35-35/P, Cortona Arezzo 52044, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MB ELETTRONICA (Owner Number: 10080933)

Owner / Operator Contact Address

P.I.P. Vallone, 35 Camucia, Cortona, IT-AR 52044, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GI Genius Module 200 GI Genius Module 300 GI Genius Module 100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2024-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Kradjian Business: Conventus Biomedical Solutions, Inc. Email: skradjian@conventusbiomed.com Phone: (858) 4012111

Related Public Records

Same Entity

MB ELETTRONICA

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 3016432796. Last updated year: 2026. Please use registration number 3016432796 when referencing this establishment in official correspondence.