BEUDAMED
    FDA Registration Active 🇨🇳 China

    BioHermes, A1C EZ Glycohemoglobin Analysis System, model A1C EZ 2

    Reg #: 3012526002 · FEI: 3012526002 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3012526002
    FEI Number
    3012526002
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.136 Mashan Meiliang Road,Binhu
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K161533

    Owner / Operator

    Firm Name
    Wuxi Biohermes Bio & Medical Technology Co., Ltd.
    Operator Number
    10051365
    Address
    No.136 Mashan Meiliang Road,Binhu
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214092
    Country
    CN
    Correspondent
    Luo Kimi

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    BioHermes, A1C EZ Glycohemoglobin Analysis System, model A1C EZ 2

    Establishment Types

    Manufacture Medical Device