BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    9011 (13L4w)

    Reg #: 9680269 · FEI: 3003705156 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    59
    Establishment Types
    2
    Classifications
    3

    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
    K180737

    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 Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    9011 (13L4w) 9018 (E14C4t) 9029 (E13C2) 9076 (I13C3f) 9062 (N13C5) 9024 (I12C5b) 9016 (I14C5T) 9038 (X14L4) UA1251 9007 (N20P6) UA1326 UA0671 (Water Standoff) 9066 (I12C4f) UA1329-S (Sterile) 9027 (T7P2m) 9032 (8L2) UA1323-S (Sterile) 2300 (bk3000, bk3500, bk5000, bkActiv) UA1328 UA1338 (Sterile) 9048 (E14CL4b) UA1322-S (Sterile) UA1232 UA1349 UA1282 9026 (X12C4) 9015 (I14C5I) UA1324 UA0672 (Rectosigmoidoscope) UA1325w (Channel Bracket) UA1344 (Sterile) 9063 (N11C5s) 9052 (20R3) 9040 (6C2) UA1337 (Sterile) UA0673 (Rectosigmoidoscope) UA1346 (Sterile) UA2379 Integrated TR Fusion Kit 2300 9085 (5C1e) UA1336 (Sterile) 9002 (9C2) 9096 (Rob12C4) 9009 (X18L5s) 9019 (E10C4) UA1345 (Sterile) 9023 (6C2s) UA1239 UA1327 9051 (14L3) UA2390 Integrated TP Fusion Kit 2300 UA1325 (Channel Bracket) UA1250 UA1339 (Sterile) 7000 (bkViewer) UA1322-S14 (Sterile) 9034 (I12C5) 9070 (18L5) 9081 (18L5s) 9077 (5P1)

    Establishment Types

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