BEUDAMED
    FDA Registration Active 🇨🇳 China

    Fipeo G-427B blood glucose monitoring system

    Reg #: 3004101980 · FEI: 3004101980 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOLAND TECHNOLOGY LTD.
    Registration Number
    3004101980
    FEI Number
    3004101980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A6B7 (BLOCK G), SHANGRONG IND. ZONE, BAOLONG 5th RD,, LONGGANG DISTRICT,
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191657

    Owner / Operator

    Firm Name
    BIOLAND TECHNOLOGY LTD.
    Operator Number
    9057599
    Address
    A6B7 (Block G), SHANGRONG IND. ZONE, BAOLONG 5TH RD., LONGGANG DISTRICT
    City
    SHENZHEN
    State
    Guangdong
    Postal Code
    518116
    Country
    CN

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Fipeo G-427B blood glucose monitoring system Bioland blood glucose monitoring system(Model:G-427B) Andesfit ADF-B27 blood glucose monitoring system(Model:G-427B) Elera G-427B blood glucose monitoring system MG1 Blood Glucose Monitoring System(Model:G-427B) Oxiline Gluco X Pro Blood Glucose Monitoring System(Model:G-427B)

    Establishment Types

    Manufacture Medical Device