BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Xiamen Boson Biotech Co., Ltd.

    SRN: CN-MF-000001096 · Tianfeng Road No. 90-94, 361021 Xiamen, China
    View on EUDAMED
    Basic UDI-DIs
    160
    Total Devices
    160
    On Market
    160
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    4

    Basic Information

    Address
    Tianfeng Road No. 90-94, 361021 Xiamen, China
    Email
    [email protected]
    Phone
    +86-592-3965101
    Website
    www.bosonbio.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 157
    Eu Ivdr 3
    Classification
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    Eu Ivd General 152
    Eu Ivd Self Testing 5
    Eu Ivd Class A 3
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 V9 061317 0006 May 26, 2024

    Market Presence

    Devices from this manufacturer are available in 4 countries across Europe.

    🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇳🇴 Norway

    Device Portfolio

    Name
    Cocaine Saliva Test Card
    MDMA Saliva Test Card
    Marijuana(THC) Saliva Test Card
    NT-proBNP Quantitative Test
    Opiate Saliva Test Card
    Procalcitonin Quantitative Test
    Rapid 2019-nCoV IgG/IgM Combo Test Card
    Rapid AFP Test Card
    Rapid Adeno/Rota Virus Antigen Combo Test Card
    Rapid Adenovirus Antigen Test Card
    Rapid Amphetamine Test Card
    Rapid Amphetamine Test Strip
    Rapid Barbiturate Test Card
    Rapid Barbiturate Test Strip
    Rapid Benzodiazepine Test Card
    Rapid Benzodiazepine Test Strip
    Rapid Buprenorphine Test Card
    Rapid Buprenorphine Test Strip
    Rapid C-reactive Protein Test Card
    Rapid CEA Test Card
    Rapid CK-MB Test Card
    Rapid Cardiac Panel Test Card
    Rapid Chikungunya IgG/IgM Combo Test Card
    Rapid Clonazepam Test Card
    Rapid Clonazepam Test Strip
    Rapid Cocaine Test Card
    Rapid Cocaine Test Strip
    Rapid Cystatin C Test Card
    Rapid D-Dimer Test Card
    Rapid DOA-10 Panel Test
    Rapid DOA-10 Panel Test Card
    Rapid DOA-10 Panel Test Cup
    Rapid DOA-10 Panel Test Cup (Split type)
    Rapid DOA-11 Panel Test
    Rapid DOA-11 Panel Test Card
    Rapid DOA-11 Panel Test Cup
    Rapid DOA-11 Panel Test Cup (Split type)
    Rapid DOA-12 Panel Test
    Rapid DOA-12 Panel Test Card
    Rapid DOA-12 Panel Test Cup
    Rapid DOA-12 Panel Test Cup (Split type)
    Rapid DOA-13 Panel Test Cup
    Rapid DOA-13 Panel Test Cup (Split type)
    Rapid DOA-14 Panel Test Cup
    Rapid DOA-14 Panel Test Cup (Split type)
    Rapid DOA-2 Panel Test
    Rapid DOA-2 Panel Test Card
    Rapid DOA-3 Panel Test
    Rapid DOA-3 Panel Test Card
    Rapid DOA-4 Panel Test
    View all 160 devices →