BEUDAMED
    FDA Registration Active 🇨🇳 China

    GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Reg #: 3010949642 · FEI: 3010949642 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    72
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Registration Number
    3010949642
    FEI Number
    3010949642
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 266 Jingsan Road, Tianjin Airport Economic Area
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213717

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    Table, Radiologic KXJ
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO

    Proprietary Names

    AIR Recon DL 1.5T 4CH Large Flex Coil 1.5T 4CH Small Flex Coil Optima MR450w 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table SIGNA Bolt 3T AIR PA XL Discovery MR450 Optima MR450w 1.5T Discovery MR750 3T SIGNA Architect Discovery MR450 1.5T SIGNA Artist Discovery MR750w 3T Sonic DL SIGNA Premier SIGNA Artist Evo SIGNA PET/MR SIGNA Champion SIGNA Sprint Select SIGNA Prime Elite SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) GE 8CH Foot Ankle Coil SIGNA Prime SIGNA Hero 3T HNU 3T LAA 3T PET/MR CMA 3T UAA 9E Express AA coil 16CH Express HNA coil 8ch Express PA coil 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 Optima MR450w GEM XP Gradient Optima MR450w GEM SIGNA Victor 1.5T Split Head Coil Optima MR 450w GEM 3T SPLIT HEAD COIL Optima MR 450w SIGNA Sprint 1.5T AIR Posterior Array Signa Voyager Premier Edition 8ch Express Suite Optima MR360 Brivo MR355 EXPRESS COIL - HEAD NECK ARRAY EXPRESS COIL - ANTERIOR ARRAY EXPRESS COIL - POSTERIOR ARRAY

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility