BEUDAMED
    EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

    XIAMEN SPACEGEN CO.,LTD.

    SRN: CN-MF-000018018 ยท XizhouRoad,Xike Town, Tong'an District, NO.2041, 361100 Xiamen City, China
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    Basic UDI-DIs
    32
    Total Devices
    32
    On Market
    32
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    32

    Basic Information

    Address
    XizhouRoad,Xike Town, Tong'an District, NO.2041, 361100 Xiamen City, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 32
    Classification
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    Eu Ivd General 32
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    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
    EGFR Gene T790M Mutation Detection Kit (Digital PCR)
    EGFR Gene T790M Mutation Detection Kit (Digital PCR)
    Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)
    Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)
    2019 Novel Coronavirus Antigen Rapid Test(Colloidal Gold)
    2019 Novel Coronavirus RNA Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    B-raf Gene Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)
    BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)
    Colorectal Cancer Related Gene Mutation Detection Kit๏ผˆHigh Throughput Sequencing๏ผ‰
    Colorectal Cancer Related Gene Mutation Detection Kit๏ผˆHigh Throughput Sequencing๏ผ‰
    Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
    Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
    EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)
    Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)
    Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry)
    Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)
    Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)
    Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    Human PAX1 Gene Methylation Detection Kit ๏ผˆMultiplex Fluorescence Polymerase Chain Reaction๏ผ‰
    Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)
    Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)
    K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    MGMT Gene Methylation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
    MLH1 Gene Methlyation Detection Kit Multiplex Fluorescence Polymerase Chain Reaction
    Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)
    Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)
    Thyroid carcinoma RET Gene Fusions Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)