BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

    SRN: CN-MF-000014156 · Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan /, 518057 Shenzhen, China
    View on EUDAMED
    Basic UDI-DIs
    334
    Total Devices
    1887
    On Market
    1887
    Off Market
    0
    Certificates
    9
    Valid
    1
    Expiring < 6mo
    0
    Countries
    3

    Basic Information

    Address
    Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan /, 518057 Shenzhen, China
    Email
    [email protected]
    Phone
    0086-755-81885636
    Website
    http//:www.mindray.com.cn

    Regulatory Overview

    Regulation
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    Eu Ivdr 271
    Eu Mdr 44
    Eu Mdd 16
    Eu Ivdd 3
    Classification
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    Eu Ivd Class B 123
    Eu Ivd Class C 82
    Eu Ivd Class A 66
    Eu Md Class 2a 26
    Eu Md Class 2b 17
    Eu Md Class 1 11
    Eu Md Class 3 6
    Eu Ivd General 3
    Device Types
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    Certificate Health

    Total
    9
    Valid
    1
    Expiring < 6mo
    0
    Expired / Withdrawn
    6
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II Section 4 CN19/41155 May 24, 2024
    MDD Annex II (excluding section 4) G10447510165 May 26, 2024
    MDD Annex II (excluding section 4) G10447610167 May 26, 2024
    MDD Annex II (excluding section 4) G10447510167 May 26, 2024
    MDD Annex II (excluding section 4) 055 G1 044751 0167 May 26, 2024
    MDD Annex II (excluding section 4) 055 G1 044751 0166 May 26, 2024
    MDD Annex II (excluding section 4) G1 044751 0166 Dec 31, 2027
    MDD Annex II (excluding section 4) No.G1 0447510166 Dec 31, 2027
    MDR QMS CN24/00005514 Aug 29, 2029 Issued

    Market Presence

    Devices from this manufacturer are available in 3 countries across Europe.

    🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands

    Device Portfolio

    Name
    BC-RET Hematology Control
    BC-RET Hematology Control
    BC-RET Hematology Control
    Immunoglobulin G Kit (Turbidimetry Method)
    25-OH-Vitamin D Total (CLIA)
    25-OH-Vitamin D Total (CLIA)
    25-OH-Vitamin D Total (CLIA)
    25-OH-Vitamin D Total (CLIA)
    25-OH-Vitamin D Total Calibrators
    5'-NT Calibrator
    5'-NT Control
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    5′-Nucleotidase Kit（Enzymatic Colorimetric Method）
    ACE Calibrator
    ACE Control
    ACTH Calibrators
    ACTH Control
    ACTH Control
    ACTH Control
    ACTH Control
    ADA Calibrator
    ADA Control
    AFP Calibrators
    AFU Control
    ALD Calibrators
    AMH Control
    AMH Control
    AMH Control
    AMH Control
    ANAESTHESIA DEVICES
    ANAESTHESIA DEVICES
    ANAESTHESIA DEVICES
    ASO/CRP/RF Triple Control
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
    Adrenocorticotropic hormone(CLIA)
    Adrenocorticotropic hormone(CLIA)
    Alanine Aminotransferase kit (IFCC Method)
    Alanine Aminotransferase kit (IFCC Method)
    Alanine Aminotransferase kit (IFCC Method)
    View all 1887 devices →