Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000337819

FEI Number

1000337819

Entity Name

FLAEM NUOVA S.P.A.

City/State/Country

Desenzano del Garda Brescia, IT

Establishment Address

Via dei Colli Storici 221, 223, 225 San Martino della Battaglia, Desenzano del Garda Brescia 25015, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FLAEM NUOVA S.P.A. (Owner Number: 9021001)

Owner / Operator Contact Address

Via dei Colli Storici 221, 223, 225 San Martino della Battaglia, Desenzano del Garda, IT-BS 25015, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

P0709EM P0907EM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	1996-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

MAUREEN OCONNELL Business: O'CONNELL REGULATORY CONSULTANTS, INC. Email: maureen@oconnellregulatory.com Phone: (978) 2071245

Related Public Records

Same Entity

FLAEM NUOVA S.P.A.

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 1000337819. Last updated year: 2026. Please use registration number 1000337819 when referencing this establishment in official correspondence.