BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Spectralis HRA+OCT and variants

    Reg #: 8043762 · FEI: 3002807157 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HEIDELBERG ENGINEERING GMBH
    Registration Number
    8043762
    FEI Number
    3002807157
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Jarecki-Str. 8
    City
    HEIDELBERG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201252

    Owner / Operator

    Firm Name
    Heidelberg Engineering GmbH
    Operator Number
    9003668
    Address
    Max-Jarecki-Str. 8
    City
    Heidelberg
    State
    Baden-Wurttemberg
    Postal Code
    69115
    Country
    DE
    Correspondent
    Rene Betz

    US Agent

    Business Name
    HEIDELBERG ENGINEERING, U.S. Corporate Office
    Contact Name
    Ricky Lopez
    Address
    10 Forge PKWY
    City
    Franklin
    State
    MA
    ZIP
    02038
    Country
    US
    Email
    [email protected]
    Phone
    508 5317820

    Products

    Device Name Product Code
    Ophthalmoscope, Laser, Scanning MYC
    Tomography, Optical Coherence OBO

    Proprietary Names

    Spectralis HRA+OCT and variants

    Establishment Types

    Manufacture Medical Device