BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    SPECTRALIS HRA + OCT and variants

    Reg #: 3008348697 · FEI: 3008348697 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Wild GmbH
    Registration Number
    3008348697
    FEI Number
    3008348697
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wildstrasse 4
    City
    Voelkermarkt Karnten
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K240221

    Owner / Operator

    Firm Name
    WILD GmbH
    Operator Number
    10032507
    Address
    Wildstrasse 4
    City
    Voelkermarkt
    State
    Karnten
    Postal Code
    9100
    Country
    AT
    Correspondent
    Christian Rabitsch

    US Agent

    Business Name
    Orasi Consulting
    Contact Name
    Lena Sattler
    Address
    226 1st Street
    City
    Bonita Springs
    State
    FL
    ZIP
    34134
    Country
    US
    Email
    [email protected]
    Phone
    440 5543706

    Products

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

    Proprietary Names

    SPECTRALIS HRA + OCT and variants

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)