BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genadyne Biotechnologies, Inc.

    Reg #: 3039256597 · FEI: 3039256597 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Genadyne Biotechnologies, Inc.
    Registration Number
    3039256597
    FEI Number
    3039256597
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    90 Welles Rd
    City
    Mystic
    State
    CT
    ZIP
    06355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142646

    Owner / Operator

    Firm Name
    Genvia Life Sciences, LLC
    Operator Number
    10093883
    Address
    90 Welles Rd
    City
    Mystic
    State
    CT
    Postal Code
    06355
    Country
    US
    Correspondent
    Andrew Goh

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Mesh, Surgical, Polymeric FTL

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility