BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Famwell Digital Pregnancy Rapid Test

    Reg #: 3024753119 · FEI: 3024753119 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BOSTON EASY BIOTECH INC
    Registration Number
    3024753119
    FEI Number
    3024753119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 Brickstone Square, Suite 104
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222305

    Owner / Operator

    Firm Name
    Boston Easy Biotech Inc
    Operator Number
    10086310
    Address
    200 Brickstone Square, Suite 104
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US
    Correspondent
    ZHI Chen

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    Famwell Digital Pregnancy Rapid Test

    Establishment Types

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