FDA Device Entity Profile: AGFA HEALTHCARE N.V.

Known Identifiers & Locations

FEI Numbers 3008794078, 3009238175, 3009238185, 3009471886

Owner Operator Numbers 9011611

Locations Covered Gent West-Vlaanderen, BE; MORTSEL Antwerpen, BE; Vienna Wien, AT; WATERLOO Ontario, CA

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3009238175	Agfa HealthCare	Gent West-Vlaanderen, BE	Develop Specifications But Do Not Manufacture At This Facility	View Details
3009238185	Agfa HealthCare GmbH	Vienna Wien, AT	Develop Specifications But Do Not Manufacture At This Facility	View Details
9616389	AGFA HEALTHCARE N.V.	MORTSEL Antwerpen, BE	Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198	View Details
9680497	AGFA HEALTHCARE INC.	WATERLOO Ontario, CA	Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.