BEUDAMED
    EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

    Shenzhen Anke High-tech Co., Ltd.

    SRN: CN-MF-000016473 ยท Block B, LingYa Industrial Zone,Tangtou No.1 Road, Shiyan Sub-district, Bao'an District, 518108 Shenzhen, China
    View on EUDAMED
    Basic UDI-DIs
    20
    Total Devices
    20
    On Market
    13
    Off Market
    7
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    5

    Basic Information

    Address
    Block B, LingYa Industrial Zone,Tangtou No.1 Road, Shiyan Sub-district, Bao'an District, 518108 Shenzhen, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
    Loading...
    Eu Mdd 19
    Eu Mdr 1
    Classification
    Loading...
    Eu Md Class 2b 16
    Eu Md Class 2a 4
    Device Types
    Loading...

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
    Loading...
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) G1 043041 0022 May 26, 2024

    Market Presence

    Devices from this manufacturer are available in 5 countries across Europe.

    ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania

    Device Portfolio

    Name
    CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
    COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
    COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
    COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
    COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
    COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
    COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
    COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
    COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
    COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
    DIGITAL MAMMOGRAPHY SYSTEMS
    DIGITAL MAMMOGRAPHY SYSTEMS
    DIRECT DIGITAL TELERADIOGRAPHS
    DIRECT DIGITAL TELERADIOGRAPHS
    EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY
    MULTIPLE CONTRAST AGENT INJECTORS
    MULTIPLE CONTRAST AGENT INJECTORS
    OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
    OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
    OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T