BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    BEURER FAR EAST LTD.

    Reg #: 3012134907 · FEI: 3012134907 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    BEURER FAR EAST LTD.
    Registration Number
    3012134907
    FEI Number
    3012134907
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 1501, 15 Floor, 118 Connaught Road west
    City
    Hong Kong SAR
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K222160

    Owner / Operator

    Firm Name
    Beurer Far East Ltd.
    Operator Number
    10094506
    Address
    Unit 1501, 15 Floor, 118 Connaught Road west
    City
    Hong Kong SAR
    State
    HK-NOTA
    Postal Code
    0000
    Country
    HK
    Correspondent
    Kin Fung

    US Agent

    Business Name
    Beurer North America LP
    Contact Name
    Nathifa Bradshaw
    Address
    1 Oakwood Blvd Ste 255
    City
    Hollywood
    State
    FL
    ZIP
    33020
    Country
    US
    Email
    [email protected]
    Phone
    954 2828108

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Unit, Oral Irrigation EFS
    Blood Pressure Cuff DXQ

    Proprietary Names

    BM92 BM35 BM82 BM32 BM72 FT58 BM50 LB26 LB25 LB15 LB46 LB10 BM55 BM62 BM81 BM26 WF13 WF23 WF03 BM31 BM27 BM25 BC33 BM47 BM33 BM22/1 BM43 BM22 FT13 BC43

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device