BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Olympus Vietnam Co. Ltd.

    Reg #: 3008040402 · FEI: 3008040402 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    173
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    Olympus Vietnam Co. Ltd.
    Registration Number
    3008040402
    FEI Number
    3008040402
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8 Street, Long Thanh Industrial Zone, An Phuoc Commune
    City
    Dong Nai City
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K951445

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Forceps, Biopsy, Electric KGE
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Snare, Flexible FDI
    Snare, Non-Electrical FGX
    Bronchoscope (Flexible Or Rigid) EOQ
    Biopsy Needle FCG
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Ligator, Esophageal MND
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Forceps, Biopsy, Non-Electric FCL
    Electrode, Electrosurgical, Active, Urological FAS
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Dislodger, Stone, Biliary LQR
    Bronchoscope Accessory KTI
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS

    Proprietary Names

    NM-400L-0525 NM-401L-0423 NM-400L-0621 NM-400U-0425 NM-400U-0623 NM-401L-0523 NM-401L-0623 NM-400L-0523 NM-401L-0525 NM-400L-0421 NM-401L-0425 NM-400U-0423 NM-400L-0623 NM-401L-0625 NM-400U-0525 NM-400U-0323 NM-400U-0523 NM-400L-0423 NM-400U-0625 NM-400L-0625 NM-400L-0425 NM-400Y-0423 MAJ-1414 FB-211D FB-241D FB-231D FB-221D KD-VC412Q-0215 KD-VC433Q-0720 KD-VC411Q-0320 KD-VC631Q-07203A KD-VC631Q-07303A KD-VC431Q-0720 KD-411Q-0730 KD-V411M-0720 KD-VC631Q-07301S KD-VC631Q-07303S KD-V411M-0330 KD-VC631Q-07201S KD-V411M-0725 KD-V411M-0320 KD-VC631Q-07203S KD-VC433Q-0730 KD-VC411Q-0330 KD-V431M-0720 KD-V411M-0730 KD-431Q-0720 KD-VC631Q-07201A KD-VC631Q-07301A KD-VC431Q-0730 KD-V431M-0730 NM-610L-0623 NM-610U-0423 NM-610L-0621 NM-610U-0323 NM-610U-0426 NM-610U-0425 NM-610L-0421 NM-610U-0523 NM-610L-0426 NM-610U-0623 NM-610L-0525 NM-610U-0326 NM-610L-0625 NM-610L-0423 NM-610L-0425 NM-610U-0525 NM-610L-0523 NM-610U-1826 NM-610L-0521 NM-610U-0625 SD-210U-15 SD-210U-25 SD-210U-10 FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 SD-240U-15 SD-240U-10 SD-230U-20 MAJ-22 HX-400U-30 B-V243Q-A B-V433P-B B-V433P-A B-V443Q-B B-V233P-B B-V443Q-A B-V243Q-B B-V233P-A NA-201SX-4022 NA-201SX-4021 KD-V611M-07302S KD-V611M-07202A KD-V611M-07251S KD-V631M-07202S KD-V611M-07251A KD-V631M-07302A KD-V611M-07201S KD-V611M-07252S KD-V611M-07252A KD-V631M-07201A KD-V631M-07201S KD-V611M-07202S KD-V631M-07202A KD-V611M-07302A KD-V611M-07301A KD-V611M-07301S KD-V611M-07201A KD-V631M-07302S KD-V631M-07301S KD-VC611Q-07303A KD-VC611Q-07203S KD-VC411Q-0730 KD-VC611Q-07203A KD-VC611Q-07201S KD-VC611Q-07301S KD-VC611Q-07301A KD-VC411Q-0720 KD-VC611Q-07201A KD-VC611Q-07303S FD-230U FD-210U FG-52D FG-54D FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush FG-232L FS-410L FS-200L FG-244NR FS-410U FG-253SX FG-460YR FG-214P FG-804L FG-600U FG-220P

    Establishment Types

    Manufacture Medical Device