BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    LBN MEDICAL A/S

    Reg #: 3009196578 · FEI: 3009196578 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    175
    Establishment Types
    1
    Classifications
    24

    Registration Details

    Registration Name
    LBN MEDICAL A/S
    Registration Number
    3009196578
    FEI Number
    3009196578
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gugvej 70
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K043559
    PMA Number
    P010025

    Owner / Operator

    Firm Name
    LBN Medical ApS
    Operator Number
    10055731
    Address
    Gugvej 70
    City
    Aalborg
    State
    Nordjylland
    Postal Code
    9210
    Country
    DK
    Correspondent
    Jesper K Nielsen

    US Agent

    Business Name
    DirectMed Imaging
    Contact Name
    Quinn Leach
    Address
    1000 County Road CB
    City
    Appleton
    State
    WI
    ZIP
    54914
    Country
    US
    Email
    [email protected]
    Phone
    858 3776143

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, X-Ray, Tomography, Computed JAK
    Biopsy Needle Guide Kit OIJ
    System, Nuclear Magnetic Resonance Imaging LNH
    Catheter, Ultrasound, Intravascular OBJ
    Automated Radiological Image Processing Software QIH
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, Image Processing, Radiological LLZ
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Mammographic IZH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    Digital Breast Tomosynthesis OTE
    Biopsy Needle FCG
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    Sonosite Probe L38 Sonosite Probe HFL 38 GE Brightspeed 16 GE Probe 4VC-D GE Probe RAB6-RS SAMSUNG V5-9 Siemens 10EV3 Philips probe C8-5 for Epiq Philips Probe C9-2 for Epiq GE L2-9D GE Logiq E10 GE C2-9D GE Optima MR450W Siemens probe 6C1 HD for S2000 Acuson Probe V5M Siemens Acuson Redwood Acuson Probe EV8C4 GE RIC5-9-H probe GE RAB4-8L probe GE Probe 3S GE Probe 4C-RS convex Siemens 18L6 HD XW8000 Workstation PHILIPS S5-1 GE TE 100024 probe GE Logiq S8 GE Probe P2D CW Doppler GE probe S1-5 GE Probe L3-12-D Hologic Selenia Dimensions 8000 Hologic Selenia Dimensions TOMO GE C2-7D probe Toshiba Probe PLT-1204BT Toshiba Probe PVT-375BT Toshiba Probe PVT-661VT Toshiba Probe PST-25BT Sonosite M-Turbo Portable Philips Probe C6-2 for Affinit PHILIPS EL18-4 Sonosite MicroMaxx Samsung V8 Ulstrasound L8-3 freesyle GE Optima CT580 Siemens 12L3 Siemens MC9-4 Siemens 10L4 GE Revolution EVO Esaote G-scan Brio 0.25T Philips Epiq CVx ultrasound GE Probe RIC5-9D BK Medical 8823 BK Medical Flex Focus 400 BK Medical 8809 BK Medical 8870 Philips Probe C10-4EC Philips Probe 3D9-3V for Epiq Philips Probe VL13-5 GE L8-18I-SC GE 10C-SC GE RAB6-D GE S6S-RS transducer GE E8C-RS transducer GE M5SC-RS Canon Aplio i800 GE Probe RIC5-9H 4D vaginal GE Discovery 710 Toshiba Probe PLT-805AT GE probe L8-18i-D intraoper GE Probe 4V-D 4D sector Canon Aquilion One Siemens 5C1 Siemens 18L6 Siemens 9EC4 Siemens 12L4 Siemens 14L5 Acuson Probe 9L4 S2000/SC2000 Philips Brightview XCT Hitachi Probe C715 for Preirus Hologic Selenia Dimensions 3D GE 6VT-D probe Vivid E9 Sonosite Convex probe C60 GE C1-5-RS GE RIC6-12D GE Vivid S70 GE Vivid IQ GE HDXT Signa 1,5T Terason 15L4 Siemens Magnetom Aera 1.5T Samsung CA2-9AD probe Samsung LA4-18B probe Philips Probe C8-5 microconvex Acuson Probe EC9-4 vaginal Acuson TEE Probe V7M GE RIC5-9W-RS probe GE E8C-RS probe GE ML6-15-D GE L8-18I-D GE Probe M4S-RS Hitachi L441 ultrasound transducer Toshiba Probe PLT-1204BX GE LightSpeed 16 Canon Vantage Elan 1.5T GE OEC 9900 Elite D2CWC GE Vivid I Portable GE Probe 12L-RS GE Probe 8C GE Probe 8C-rs Aquilion Prime Hologic Selenia Dimensions 3000 2D Hologic Selenia Dimensions TOMO 3D Hologic Selenia Dimensions 8000 TOMO Philips D2cwc Philips Probe 3D9-3V for IU22 Philips probe L17-5 for IU22 PHILIPS X5-1 GE 3SP-D Hologic 3Dimensions Hologic Selenia Dimensions 5000 3D Hologic Selenia Dimensions 5000 Hologic Selenia Dimensions 8000 3D Philips CX50 GE Probe 4C-SC 1.8-5 MHz Ziehm Vision RFD GE Probe RIC5-9A-RS Acuson probe 4V1C Siemens 4V1C GE Probe RAB4-8-RS4D abdominal GE C16-D probe E9 XD clear PHILIPS L12-3 Philips Probe X7-2 for Epiq Philips probe L12-3 for Epiq 7 Philips probe V6-2 for Epiq Philips probe C5-1 for Epiq 7 Philips Probe L18-5 for Epiq Philips Probe L15-7IO for Epiq PHILIPS C5-1 PHILIPS C10-3V Philips S7-3T transducer Logiq Fortis GE Probe BE9CS-D GE L8-18I-D probe GE Optima 660 Siemens 18H6 Toshiba Probe PVT-781VT Philips XL14-3 GE probe 4C Canon PVT-712BT Siemens EC9-4W for X600/X700 Siemens Probe VF12-4 for X700 Siemens EC9-4 GE HDxT 1.5T MRI Philips Probe BP10-5EC Philips 3D9-3V for Clearvue PHILIPS L12-5 Arcadis Varic GE OEC 9800 C-ARM Philips X7-2T Philips L12-3 GE RAB6-RS GE IC9-RS Siemens 15L4 For Sequoia Siemens 9C2 Siemens Somatom Drive Siemens CT Force GE L4-12T-RS GE L10-22-RS TEK Medical Systems LLC, DBA All Imaging Systems Samsung CA3-10A BK MEDICAL 8818 Siemens Magnetom Verio 3T Philips probe L12-3 for Epiq 5 Philips probe C10-3V Epiq Philips Probe S12-4 for Epiq Medrad Stellant Dual Injector

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device