BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SoClean, Inc.

    Reg #: 3009534409 · FEI: 3009534409 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    5
    Classifications
    2

    Registration Details

    Registration Name
    SoClean, Inc.
    Registration Number
    3009534409
    FEI Number
    3009534409
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Vose Farm Road
    City
    Peterborough
    State
    NH
    ZIP
    03458
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243815

    Owner / Operator

    Firm Name
    SoClean, Inc.
    Operator Number
    10039873
    Address
    1 Vose Farm Road
    City
    Peterborough
    State
    NH
    Postal Code
    03458
    Country
    US
    Correspondent
    George Peters

    Products

    Device Name Product Code
    Disinfectant, Medical Devices LRJ
    Respiratory Accessory Microbial Reduction Device. QXQ

    Proprietary Names

    SoClean Family of Products (SC1200, SC1400) SoClean 3+ Bacterial Reduction Device

    Establishment Types

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