Flaem Nuova S P A

FDA Filings

This page includes the latest FDA filings for Flaem Nuova S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1000337819
• FEI Number: 1000337819
• Name: FLAEM NUOVA S.P.A.
• Owner & Operator: FLAEM NUOVA S.P.A.
• Contact Address: Via dei Colli Storici 221, 223, 225 San ; Desenzano del Garda IT-BS Brescia 25015 IT
• US Agent:
  • MAUREEN - O'CONNELL
  • O'CONNELL REGULATORY CONSULTANTS, INC.
  • 978 2071245
  • maureen@oconnellregulatory.com
• Importing Logistics Registration:
  • Importer: Advanced Rx
  • Address: 5205 Militia Hill Road, Ste 200 ; Plymouth Meeting, PA 19462 UNITED STATES
• Importing Logistics Registration:
  • Importer: ALGUNAS INC. DBA WOODLAND HILLS PHARMACY
  • Address: 20631 Ventura Blvd. Suite 305 ; Woodland Hills, CA 91364 UNITED STATES
• Importing Logistics Registration:
  • Importer: Cascade Specialty Pharmacy
  • Address: 325 NE Hostmark St ; Breidablick, WA 98370 UNITED STATES
• Importing Logistics Registration:
  • Importer: FORTE RX
  • Address: 651 VIA ALONDRA 708 ; Camarillo, CA 93012 UNITED STATES
• Importing Logistics Registration:
  • Importer: Harbor Compounding Pharmacy
  • Address: 2000 Harbor Blvd, Suite C100 ; Costa Mesa, CA 92627 UNITED STATES
• Importing Logistics Registration:
  • Importer: Hill Country Apothecary
  • Address: 1310 Ranch Road 620S Ste A-1 ; Austin, TX 78734 UNITED STATES
• Importing Logistics Registration:
  • Importer: YOUR HEALTH PHARMACY
  • Address: 12 N FEDERAL HIGHWAY A ; Pompano Beach, FL 33062 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via dei Colli Storici 221, 223, 225 San Martino della Battaglia ; Desenzano del Garda Brescia, 25015 IT
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08018294012793 FLAEM NUOVA SPA	FLAEM Rhino Clear Sprint DR12P00	2020-07-20
PMN K062484 FLAEM NUOVA S.P.A.	FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS	2007-06-08
PMN K062014 FLAEM NUOVA S.P.A.	FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB	2007-03-22
JPW FLAEM NUOVA S.P.A.	P0907EM	1996-10-22
JPW FLAEM NUOVA S.P.A.	P0709EM	1996-10-22

Related Finance Registrations

NCAGE Code	AD968	FLAEM NUOVA SPA
CAGE Code	AD968	FLAEM NUOVA SPA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081533730	Genova,Italy -> Long Beach, California	VACUUM PACKAGING MACHINES (MAXIMA2) + SPARE PARTS HTS 85098000+39191019+ 49111000	6 PKG
201909188427	La Spezia,Italy -> Seattle, Washington	VACUUM SEALERS FOR FOOD STORAGE AND ROOLS, BAGS HS 3919 1019 HS 8509 8000	11 PKG
2018082349362	Genova,Italy -> New York/Newark Area, Newark, New Jersey	SPARE PARTS FOR VACUUM MACHINES HS 850980 HS 391910 DAP 15010 BEAVER FALLS,PA	2 PKG
201807197700	Genova,Italy -> Seattle, Washington	VACUUM PACKAGING MACHINES AND SPARE PARTS HTS CODE: 8509 8000 ROLLS AN BAGS HTS CODE: 3919 1019 VACUUM HOOD WITH HOSE HTS CODE: 3923 0000	224 PKG