BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    18L5s

    Reg #: 9680269 · FEI: 3003705156 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    BK MEDICAL APS
    Registration Number
    9680269
    FEI Number
    3003705156
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MILEPARKEN 34
    City
    HERLEV Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K231764

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    18L5s E14C4t 6C2 X12C4 X14L4 5C1e 20R3 5P1e 6C2s I14C5I 14L3e E10C4 E13C2 E11C3b N11C5s E14CL4b 9c2 13L4w 8L2 I14C5T Ultrasound System 1300 I12C5b X18L5s N13C5 14L3 18L5

    Establishment Types

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