Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026753391

FEI Number

3026753391

Entity Name

VISIA LAB SRL

City/State/Country

SAN GIOVANNI VALDARNO Arezzo, IT

Establishment Address

VIA MARTIRI DELLA LIBERTA 95/D, SAN GIOVANNI VALDARNO Arezzo 52027, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VISIA LAB SRL (Owner Number: 10085668)

Owner / Operator Contact Address

VIA MARTIRI DELLA LIBERTA 95/D, SAN GIOVANNI VALDARNO, IT-AR 52027, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

dIFine ANCA Classifier dIFine M1 with camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2025-06-25
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2025-06-25
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2025-07-23

Official Correspondent

Silvia Fantechi

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

VISIA LAB SRL

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 3026753391. Last updated year: 2026. Please use registration number 3026753391 when referencing this establishment in official correspondence.