Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002809633

FEI Number

3002809633

Entity Name

Agfa Gevaert N.V.

City/State/Country

Mortsel Antwerpen, BE

Establishment Address

27 Septestraat, Mortsel Antwerpen B 2640, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Agfa Gevaert N.V. (Owner Number: 10023132)

Owner / Operator Contact Address

27 Septestraat, Mortsel, BE-VAN B 2640, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drystar DT 2 Mammo Drystar DT 2 B CP-BU M Radiomat LS Ortho CP-GU M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2007-11-06

Official Correspondent

Ludo De Donder

US Agent Details

ShaeAnn Cavanagh Email: shaeann.cavanagh@agfa.com Phone: (864) 3135016

Related Public Records

Same Entity

Agfa Gevaert N.V.

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 3002809633. Last updated year: 2026. Please use registration number 3002809633 when referencing this establishment in official correspondence.