BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIAGNOSYS LLC

    Reg #: 1221363 · FEI: 1221363 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    DIAGNOSYS LLC
    Registration Number
    1221363
    FEI Number
    1221363
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    55 TECHNOLOGY DR STE 100
    City
    Lowell
    State
    MA
    ZIP
    01851
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221471

    Owner / Operator

    Firm Name
    DIAGNOSYS LLC
    Operator Number
    1221363
    Address
    55 Technology Drive, Suite 100
    City
    Lowell
    State
    MA
    Postal Code
    01851
    Country
    US
    Correspondent
    Jeff D Farmer

    Products

    Device Name Product Code
    Preamplifier, Ac-Powered, Ophthalmic HLT
    Stimulator, Photic, Evoked Response GWE
    Electrode, Corneal HLZ
    Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation OUM
    Pupillometer, Ac-Powered HLG

    Proprietary Names

    Envoy monitor Profile Espion E3 ColorBurst stimulator ColorFlash stimulator S2 controller LCD monitor ColorDome stimulator DTL Plus Electrode MaculoScope E3 DiagnosysFST Profile DiagnosysFST E3 Dark Adaptometer Profile Dark Adaptometer Profile Pupillometer E3 Pupillometer GoldLens

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility