BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SAEHAN CORPORATION

    Reg #: 8040255 · FEI: 3010581156 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    SAEHAN CORPORATION
    Registration Number
    8040255
    FEI Number
    3010581156
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23-29, Bongamgongdan 13-gil, Masanhoewon-Gu (Masan Free Trade Zone)
    City
    Changwon Gyeongnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K052309

    Owner / Operator

    Firm Name
    SAEHAN CORPORATION
    Operator Number
    8040255
    Address
    23-29, Bongamgongdan 13-gil, Masanhoewon-Gu (Masan Free Trade Zone)
    City
    Changwon
    State
    Gyeongnam
    Postal Code
    51342
    Country
    KR
    Correspondent
    Sunyoung Park

    Products

    Device Name Product Code
    Dynamometer, Ac-Powered LBB
    Goniometer, Nonpowered KQW
    Tape, Measuring, Rulers And Calipers FTY
    Discriminator, Two-Point GWI
    Components, Exercise IOD
    Apparatus, Traction, Non-Powered HST
    Dynamometer, Nonpowered HRW
    Pinwheel GWY
    Exerciser, Non-Measuring ION
    Gauge, Depth HTJ

    Proprietary Names

    SAEHAN Digital Pinch Gauge North Coast Digital Pinch Gauge SAEHAN Digital Hand Dynamometer(DHD-3) SAEHAN Digital Hand Dynamometer(DHD-1) North Coast Digital Hand Dynamometer SAEHAN Digital Hand Dynamometer Multi-Finger Flexion Goniometer(Finger Flexion Gauge) Finger Goniometer SAEHAN X-Ray Goniometer SAEHAN Goniometer SAEHAN Pocket Goniometer SAEHAN Finger Goniometer SAEHAN 6 pcs Goniometer Set 6-Piece Goniometer Set Finger Circumference Gauge Skinfold Caliper SAEHAN Skinfold Caliper Three-Point discriminator SAEHAN Hand Strap for Upper Extremity Exercise(UEE) SAEHAN Upper Extremity Exercise Set SAEHAN Long Front Leg for Upper Extremity Exercise long leg brace kit for deluxe SAEHAN pedal exerciser SAEHAN Extension Arm for Upper Extremity Exercise SAEHAN Parts for Clinical Model Chair Cycle SAEHAN Long Leg Brace Set SAEHAN Bent Leg Brace Set upper extremity exercise kit for deluxe SAEHAN pedal exerciser Iron weights for pulley weight system SAEHAN double handle weight system SAEHAN Cast-Iron Weight Plate SAEHAN Metal Handle(Pair) for Pulley Weights SAEHAN Twin Ball(pair) and Rope for Pulley Weights SAEHAN Guide Rod for Pulley Weights, each SAEHAN Single Column Duplex Pulley Weights SAEHAN Chest Pulley Weights SAEHAN single pulley weight system SAEHAN triple pulley weight system SAEHAN Duplex Pulley Weights SAEHAN Triplex Pulley Weights Back-Leg-Chest Dynamometer SAEHAN Hydraulic Hand Dynamometer Hydraulic Hand Dynamometer Spring Hand Dynamometer North Coast Hydraulic Hand Dynamometer SAEHAN Squeeze Dynamometer Wartenberg Pinwheel SAEHAN chair cycle pedal exerciser Chair Cycle, Clinic Model SAEHAN Chair Cycle, Home Model Chair Cycle, Deluxe Home Model SAEHAN Chair Cycle, Clinical Model SAEHAN deluxe chair cycle pedal exerciser SAEHAN Mechanical Pinch Gauge SAEHAN Hydraulic Pinch Gauge Hydraulic Pinch Gauge North Coast Hydraulic Pinch Gauge

    Establishment Types

    Manufacture Medical Device