BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    UA1325w (Channel Bracket)

    Reg #: 9680269 · FEI: 3003705156 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    58
    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
    K223830

    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    UA1325w (Channel Bracket) 9024 (I12C5b) UA0671 (Water Standoff) 9026 (X12C4) 9070 (18L5) UA2379 Integrated TR Fusion Kit 2300 9009 (X18L5s) 9076 (I13C3f) UA1250 UA1326 9015 (I14C5I) UA1325 (Channel Bracket) UA0672 (Rectosigmoidoscope) 9081 (18L5s) UA1345 (Sterile) 9034 (I12C5) 9077 (5P1) 9040 (6C2) 9002 (9C2) UA1337 (Sterile) 9051 (14L3) 9011 (13L4w) 9096 (Rob12C4) 9038 (X14L4) UA1336 (Sterile) UA2390 Integrated TP Fusion Kit 2300 9023 (6C2s) 9029 (E13C2) UA1324 9063 (N11C5s) 9048 (E14CL4b) UA1322-S (Sterile) 9032 (8L2) 2300 (bk3000, bk3500, bk5000, bkActiv) 9018 (E14C4t) UA1329-S (Sterile) 9085 (5C1e) 9016 (I14C5T) 9078 (l13C3fx) UA1338 (Sterile) 9066 (I12C4f) UA1251 UA1344 (Sterile) UA1327 UA1328 UA1232 UA1322-S14 (Sterile) UA1349 UA1346 (Sterile) 9019 (E10C4) UA1323-S (Sterile) UA1339 (Sterile) 9007 (N20P6) 9052 (20R3) UA0673 (Rectosigmoidoscope) UA1239 9062 (N13C5) UA1282

    Establishment Types

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