BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    BK MEDICAL APS

    Reg #: 9680269 · FEI: 3003705156 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    116
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    BK MEDICAL APS
    Registration Number
    9680269
    FEI Number
    3003705156
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MILEPARKEN 34
    City
    HERLEV Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K081323

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

    Proprietary Names

    UA1329-S (Sterile) UA1339 (Sterile) UA1257-S14 (Sterile) UA1323-S (Sterile) UA1322-S (Sterile) UA1257S17E (Sterile) UA1322-S14 (Sterile) 9015 (I14C5I) UA0673 (Rectosigmoidoscope) 9040 (6C2) 9070 (18L5) UA0672 (Rectosigmoidoscope) 9096 (Rob12C4) 9002 (9C2) 9052 (20R3) UA0671 (Water Standoff) UA1232 UA2379 Integrated TR Fusion Kit 2300 9066 (I12C4f) 9019 (E10C4) 9026 (X12C4) UA1325 (Channel Bracket) 9062 (N13C5) 9024 (I12C5b) 9016 (I14C5T) UA1282 UA1324 9018 (E14C4t) UA1349 9048 (E14CL4b) 9034 (I12C5) 2300 (bk3000, bk3500, bk5000, bkActiv) UA1251 9063 (N11C5s) UA1326 UA2390 Integrated TP Fusion Kit 2300 9085 (5C1e) 9078 (l13C3fx) 9023 (6C2s) 9051 (14L3) UA1328 9081 (18L5s) 9032 (8L2) 9009 (X18L5s) 9038 (X14L4) 9007 (N20P6) 9077 (5P1) UA1250 UA1325w (Channel Bracket) UA1327 UA1239 9076 (I13C3f) 9011 (13L4w) 9029 (E13C2) bkActiv S Series UA1345 (Sterile) UA1338 (Sterile) UA1346 (Sterile) UA1337 (Sterile) UA1336 (Sterile) UA1344 (Sterile) E14CL4b 14L3e 13L4w Ultrasound System 1300 I14C5T 18L5 8L2 5P1e 6C2s E11C3b 5C1e 20R3 X12C4 X14L4 I14C5I X18L5s 6C2 I12C5b 18L5s 14L3 E14C4t N11C5s 9c2 N13C5 E10C4 E13C2 8820e 8848 8823 8838 8816 8819 8824 8863 8826 8870 8667 8862 8808e 2052 8670 8818 8811 UA1256 8666-RF 8809 1202 (Flex Focus) 8815 9008 (E11C3b) 9086 (14L3e) UA0672 (Rectosygmoidoscope) 1300 (bkSpecto) 9087 (5P1e) UA0673 (Rectosygmoidoscope) 7000 (bkViewer)

    Establishment Types

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