Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011483384

FEI Number

3011483384

Entity Name

EUROPROSAN SPA

City/State/Country

MARNATE Varese, IT

Establishment Address

VIA TONALE 157, MARNATE Varese 21050, IT

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

EUROPROSAN SPA (Owner Number: 10091208)

Owner / Operator Contact Address

VIA TONALE 157, MARNATE, IT-VA 21050, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLUFSAN Europrosan Europrosan FLUFSAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2024-09-06
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-09-06

Official Correspondent

Annalisa Caldiroli

US Agent Details

Gustavo Adolfo Santamarina Email: gsny101@gmail.com Phone: (646) 2623581

Related Public Records

Same Entity

EUROPROSAN SPA

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 3011483384. Last updated year: 2026. Please use registration number 3011483384 when referencing this establishment in official correspondence.