Agfa Healthcare

FDA Filings

This page includes the latest FDA filings for Agfa Healthcare. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009238175
FEI Number3009238175
NameAgfa HealthCare
Owner & OperatorAGFA HEALTHCARE N.V.
Contact Address375 Hagey Blvd
Waterloo CA-ON Ontario N2L 6R5 CA
Official Correspondent
  • Christopher Ball
  • 1-519-7466210-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMoutstraat 100
Gent West-Vlaanderen, B-9000 BE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Agfa HealthCare [AGFA HEALTHCARE N.V.]
Enterprise Imaging Desktops2015-01-19
Agfa HealthCare [AGFA HEALTHCARE N.V.]
Enterprise Imaging Desktops2011-08-15

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020060367722Le Havre,France -> New York, New YorkMATERIEL DE CRDIOLOGIE HS CODE 3701301 PKG
2019071684360Le Havre,France -> New York/Newark Area, Newark, New JerseyPRODUITS PHARMACEUTIQUES HS CODE 370130001 PKG
2018070528203Le Havre,France -> New York/Newark Area, Newark, New JerseyPRODUITS DE SANTE HS CODE 370130001 PKG
2018070449476Le Havre,France -> New York/Newark Area, Newark, New JerseyPRODUITS DE SANTE HS CODE 370130001 PKG
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