BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AGFA-GEVAERT HEALTHCARE GMBH

    Reg #: 9613152 · FEI: 3003772616 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    AGFA-GEVAERT HEALTHCARE GMBH
    Registration Number
    9613152
    FEI Number
    3003772616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MAX PLANCK STRASSE 1
    City
    PEISSENBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K072680

    Owner / Operator

    Firm Name
    Agfa N.V.
    Operator Number
    10058267
    Address
    Septestraat 27
    City
    Mortsel
    State
    BE-NOTA
    Postal Code
    B-2640
    Country
    BE
    Correspondent
    Koen Vervoort

    US Agent

    Business Name
    Agfa US Corp
    Contact Name
    ShaeAnn Cavanagh
    Address
    580 Gotham Parkway
    City
    Carlstadt
    State
    NJ
    ZIP
    07072
    Country
    US
    Email
    [email protected]
    Phone
    864 3135016

    Products

    Device Name Product Code
    Camera, Multi Format, Radiological LMC
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Instrument, Quality-Assurance, Radiologic LHO
    Radiology-Diagnostic Kit OIP
    System, X-Ray, Tomographic IZF
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    Drystar AXYS Crystal-M Imager Drystar AXYS XL DR 600 Pixium 4343 RCE Pixium 4343 RGE DR 600 FLFS Overlay NX 3 VALORY CR Advanced Reader CR Multi-Format Reader CR HD5S General Detector CR 15-X CR 12-X CR MD1 General Set CR 30-X CR MD4T FLFS Set CR MD4T General Set DX-D Imaging Package DR 14s DR 10s Auto QC2 Mammography Crystal Imager Drystar 5302 CR MD4 General Set CR MD4 General Set SR CR 25 Digitizer CR MD4.1 FLFS Set CR MM3 Extremities Set CR 85-X Radiology Diagnostic Kit 4343 C Radiology Diagnostic Kit 4343 R/F Radiology Diagnostic Kit 4343 G NX 4 Pixium RAD 4343 MUSICA Engine CR 10-X CR Reader CR MD4R General Set CR HD5 General Detector CR MD4 General Set HR CR HD5 AEC Detector CR MD4R FLFS Set CR MD4R General SR Set DX-G CR HD5 General SR Detector CR HD5 FLFS Detector CR HD5 FLFS Cassette CR HD5 General Cassette Drystar 5503 DR 400 FLFS DR 400 DX-M CR HD5 Extremities Detector

    Establishment Types

    Manufacture Medical Device