BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Microlife WatchBP - OFFICE 2G

    Reg #: 3010381606 · FEI: 3010381606 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EMSERE BV
    Registration Number
    3010381606
    FEI Number
    3010381606
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zaalbergweg 9
    City
    Leiden Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K200297

    Owner / Operator

    Firm Name
    Emsere, Inc
    Operator Number
    10047331
    Address
    Zaalbergweg 9
    City
    Leiden
    State
    Zuid-Holland
    Postal Code
    2314XS
    Country
    NL
    Correspondent
    Patrice Gerard

    US Agent

    Business Name
    Emsere, Inc.
    Contact Name
    Nick Floars
    Address
    627 Highway 74 South, Suite 220
    City
    Peachtree City
    State
    GA
    ZIP
    30269
    Country
    US
    Email
    [email protected]
    Phone
    770 8383959

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Microlife WatchBP - OFFICE 2G

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device