BEUDAMED
    EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

    Acon Biotech (Hangzhou) Co., Ltd.

    SRN: CN-MF-000006977 ยท Zhenzhong Road No.210, 310030 Hangzhou, China
    View on EUDAMED
    Basic UDI-DIs
    101
    Total Devices
    130
    On Market
    130
    Off Market
    0
    Certificates
    6
    Valid
    0
    Expiring < 6mo
    0
    Countries
    32

    Basic Information

    Address
    Zhenzhong Road No.210, 310030 Hangzhou, China
    Email
    [email protected]
    Phone
    +86 571 87775615
    Website
    https://www.aconbio.com/index.html

    Regulatory Overview

    Regulation
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    Eu Ivdd 76
    Eu Ivdr 17
    Eu Mdd 8
    Classification
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    Eu Ivd Self Testing 42
    Eu Ivd Annex 2 List B 32
    Eu Ivd Class A 17
    Eu Md Class 2a 8
    Eu Ivd General 2
    Device Types
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    Certificate Health

    Total
    6
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    6
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 V9 042074 0032 May 26, 2024
    MDD Annex V G2 042074 0030 May 26, 2024
    MDD Annex V G2 042074 0030 May 26, 2024
    IVDD Annex IV (excluding sections 4, 6) V1 042074 0026 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) No. V1 042074 0026 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) V1 042074 0026 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 32 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

    Device Portfolio

    Name
    FIAflex FIA Analyzer
    FIAflex FIA Analyzer
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva))
    Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
    Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
    Influenza A/B Rapid Test (Self-Testing)
    MIssion TRIG Triglycerides Test Devices
    Mission 3D Hematology Reagent (Cyto-Diluent)
    Mission 3D Hematology Reagent (Cyto-Lyser)
    Mission 3D Hematology Reagent (Mi-Po Cleaner)
    Mission CHOL Total Cholesterol Test Devices
    Mission Cholesterol Control Solution
    Mission Cholesterol Meter
    Mission Cholesterol Meter
    Mission Cholesterol Monitoring System
    Mission Cholesterol Test Device 3-in-1 Lipid Panel
    Mission Cholesterol Test Device 3-in-1 Lipid Panel
    Mission HDL High Density Lipoprotein Test Devices
    Mission Lancets
    Mission Safety Lancets I
    Mission Safety Lancets โ…ข
    Mission U120 Smart Urine Analyzer
    Mission U120 Smart Urine Analyzer
    Mission U500 Urine Analyzer
    Mission U500 Urine Analyzer
    Mission Ultra Cholesterol Control Solution
    Mission Ultra Cholesterol Meter
    Mission Ultra Cholesterol Monitoring System
    Mission Ultra Hemoglobin Control Solution
    Mission Ultra Hemoglobin Test Strips
    Mission Ultra Hemoglobin Testing System
    Mission Ultra Total Cholesterol Test Strips
    On Call Blood Uric Acid Test Strips
    On Call Blood Uric Acid Test Strips
    On Call EZ II Blood Glucose Meter
    On Call EZ II Blood Glucose Monitoring System
    On Call Extra Blood Glucose Meter
    On Call Extra Blood Glucose Meter
    On Call Extra Blood Glucose Meter
    On Call Extra Blood Glucose Monitoring System
    On Call Extra Blood Gucose Test Strips
    On Call Extra Blood Gucose Test Strips
    On Call Extra Glucose Control Solution
    On Call GU Dual Blood Glucose and Uric Acid Meter
    On Call Lancets
    View all 130 devices โ†’