BEUDAMED
    FDA Registration Active 🇨🇳 China

    SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.

    Reg #: 3003202425 · FEI: 3003202425 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    96
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.
    Registration Number
    3003202425
    FEI Number
    3003202425
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    278 ZHOU ZHU RD
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K133590

    Owner / Operator

    Firm Name
    Siemens Healthineers AG
    Operator Number
    8010024
    Address
    Karlheinz-Kaske-Str. 5, --
    City
    Erlangen
    State
    DE-NOTA
    Postal Code
    91052
    Country
    DE

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard
    City
    MALVERN
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 2359839

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Holder, Radiographic Cassette, Wall-Mounted IXY
    System, Image Processing, Radiological LLZ
    System, X-Ray, Angiographic IZI
    Device, Beam Limiting, X-Ray, Diagnostic KPW

    Proprietary Names

    Somatom Perspective 16 & 32 slice config SOMATOM Emotion Systems - VC20 SOMATOM go.Top with SOMARIS/10 syngo CT VB20 SOMATOM go.Now with SOMARIS/10 syngo CT VB20 SOMATOM go.Up with SOMARIS/10 syngo CT VB20 SOMATOM go.Sim with SOMARIS/10 syngo CT VB20 SOMATOM go.All with SOMARIS/10 syngo CT VB20 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB20 SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 MULTIX Impact E SOMATOM Scope Power (with syngo® CT VC30-easyIQ version) SOMATOM Scope (with syngo® CT VC30- easyIQ version) Cios Select (VA21) Flat Panel SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB10 SOMATOM X.cite with SOMARIS/10 syngo CT VB10 SOMATOM X.ceed with SOMARIS/10 syngo CT VB10 SOMATOM go.Up with SOMARIS/10 syngo CT VB10 SOMATOM go.Top with SOMARIS/10 syngo CT VB10 SOMATOM go.All with SOMARIS/10 syngo CT VB10 SOMATOM go.Now with SOMARIS/10 syngo CT VB10 SOMATOM go.Sim with SOMARIS/10 syngo CT VB10 Cios Select Cios Select (VA20) Bucky Wall Stand Family SOMATOM go.All with SOMARIS/10 syngo CT VA40 SOMATOM go.Up with SOMARIS/10 syngo CT VA40 SOMATOM go.Sim with SOMARIS/10 syngo CT VA40 SOMATOM X.cite with SOMARIS/10 syngo CT VA40 SOMATOM X.ceed with SOMARIS/10 syngo CT VA40 SOMATOM go.Top with SOMARIS/10 syngo CT VA40 SOMATOM go.Now with SOMARIS/10 syngo CT VA40 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VA40 Scan&GO Software with SOMARIS/10 syngo CT VA40 SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 SOMATOM go.Now SOMATOM go.Up AXIOM ARTIS U Multix Fusion Max Multix Fusion VA30 and VA40 Multix Fusion Multix Fusion Max w/SW VF10 SOMATOM X.cite with SOMARIS/10 syngo CT VA 30 Scan&GO with SOMARIS/10 syngo CT VA 30 MULTIX Impact Cios Select Flat Panel (VA21F) Cios Select (VA21) Flat Panel System Cios Select Diamond Multix Select DR SOMATOM X.ceed SOMATOM X.cite syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems SOMATOM Perspective (with syngo® CT VC30-easyIQ version) SOMATOM Perspective Somatom Scope Power Somatom Scope Cios Select (VA21) Image Intensifier Cios Select VA10 MULTIX Impact C Collimator AIC Family Collimator RFU Family Collimator Angio Family Collimator N Family Collimator MFD Family Collimator LFD Family Collimator ML03 Collimator SFD Family Collimator N / N II Family Collimator CARD Family Collimator ML02 Family Collimator Mammo Family Collimator Mobile-C Family MULTIX Impact E VB20 SOMATOM go.TOP SOMATOM go.All Scan&GO SOMATOM Emotion 6 (with syngo® CT VC30-easyIQ version) SOMATOM Emotion 6/16 SOMATOM go.Now, with SOMARIS/10 syngo CT VA30 SOMATOM go.Open Pro, with SOMARIS/10 syngo CT VA30 SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 SOMATOM go.All, with SOMARIS/10 syngo CT VA30 SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 Scan&Go, with SOMARIS/10 syngo CT VA30 SOMATOM SPIRIT SOMATOM X.cite, with SOMARIS/10 syngo CT VA30 (Update) Scan&GO, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Open Pro, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Now, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.All, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 Cios Select (VA21) Image-Intensifier SOMATOM Project P68

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198