BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARESTREAM HEALTH, INC.

    Reg #: 3015532525 · FEI: 3015532525 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    CARESTREAM HEALTH, INC.
    Registration Number
    3015532525
    FEI Number
    3015532525
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    882 Linden Ave.
    City
    Rochester
    State
    NY
    ZIP
    14625
    Country
    US

    Owner / Operator

    Firm Name
    Carestream Health, Inc.
    Operator Number
    9097221
    Address
    150 Verona Street
    City
    Rochester
    State
    NY
    Postal Code
    14608
    Country
    US
    Correspondent
    Alyssa J Haig

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Confocal Optical Imaging OWN
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS
    Light Source, Fiberoptic, Routine FCW

    Proprietary Names

    SPY Lymphatics Kit with SPY AGENT GREEN SPY Lymphatics Pack with SPY AGENT GREEN SPY Minimally Invasive Surgery Pack with SPY AGENT GREEN SPY Minimally Invasive Surgery Kit with SPY AGENT GREEN SPY-PHI Pack with SPY AGENT GREEN SPY-PHI Kit with SPY AGENT GREEN Firefly- Fluorescence Imaging Procedure Kit; Box of 6 Kits Firefly- Fluorescence Imaging Procedure Kit; 1 procedure Kit SPY Elite Pack with SPY AGENT GREEN SPY Elite Kit with SPY AGENT GREEN

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)