BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    AIZU OLYMPUS CO., LTD.

    Reg #: 9610595 · FEI: 3002964398 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    217
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    AIZU OLYMPUS CO., LTD.
    Registration Number
    9610595
    FEI Number
    3002964398
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-1-1 Niiderakita
    City
    AIZUWAKAMATSU-SHI Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K013617

    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
    Laparoscope, General & Plastic Surgery GCJ
    Colonoscope And Accessories, Flexible/Rigid FDF
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Endoscopic Irrigation/Suction System OCX
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Bronchoscope (Flexible Or Rigid) EOQ
    Gastroscope And Accessories, Flexible/Rigid FDS
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Led Light Source NTN
    Endoscopic Bite Block MNK
    Spatial Imaging For Display Of Endoscope Position PGU
    Enteroscope And Accessories FDA
    Accessories, Cleaning, For Endoscope FEB
    Laparoscope, Gynecologic (And Accessories) HET
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Endoscope Channel Accessory ODC
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Source, Carrier, Fiberoptic Light EQH
    Cystourethroscope FBO
    Accessories, Cleaning Brushes, For Endoscope MNL
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    MAJ-1214 MH-438 MAJ-855 MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories MAJ-525 BF-1TH190 BF-Q190 BF-H190 MAJ-1710 MAJ-1715 MAJ-1711 MD-252 MH-985 MAJ-2431 MAJ-2437 CV-1500 MAJ-920 CF-H170I CF-H170L MA-651 MAJ-1632 MB-142 MA-392 MA-474 MAJ-1025 MH-856 MH-946 MAJ-1026 MAJ-419 MD-227 MAJ-1024 MH-948 MH-966 MH-944 MH-553 MH-974 MAJ-1878 MAJ-1898 UPD-3 MAJ-1899 MAJ-1907 MAJ-1880 MAJ-1879 MAJ-1938 MAJ-1881 MAJ-1890 MH-999E TJF-Q190V CV-190 CLV-190 CF-HQ190I CF-HQ190L MAJ-1817 CF-H190I CF-H190L PCF-PH190I MAJ-215 PCF-H190L PCF-PH190L PCF-H190I MAJ-1933 GF-UCT180 MAJ-350 MAJ-629 FB-433D MAJ-1538 MAJ-2358 MAJ-2144 OER-Elite MAJ-840 MAJ-865 3DV-190 MAJ-2053 LTF-190-10-3D MAJ-2054 D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 MAJ-1838 MAJ-1837 OER-MINI MAJ-1937 MAJ-1836 MAJ-1904 MAJ-1511 MAJ-1514 MAJ-1513 MAJ-1515 MAJ-1516 CYF-5 MAJ-1413 MAJ-2092 ENF-VH ENF-V3 OTV-S500 ENF-VH2 ENF-V4 MB-156 PJF-160 GIF-XP190N URF-V3R URF-P7 URF-P7R URF-V3 CYF-VHA CYF-VH MAJ-207 MA-238 GIF-1100 CF-HQ1100DL CF-HQ1100DI MAJ-1077 MAF-TM2 MAJ-222 MAF-DM2 MAF-GM2 MH-155 MAJ-1430 CV-150 MAJ-1592 MAJ-1466 MAJ-941 MU-1 MAJ-1391 MAJ-905 MAJ-1981 MB-264 MAJ-960 MH-443 MAJ-879 MB-358 MAJ-1586 MB-155 MAJ-1584 MAJ-900 Light carrier, fiber optic Throat microphone Light Source GIF-EZ1500 CF-EZ1500DL CF-EZ1500DI PCF-HQ190L PCF-H190TI PCF-HQ190I PCF-H190TL TJF-Q170V LTF-S190-5 MAJ-1379 MAJ-2138 MAJ-2119 MAJ-2116 MAJ-2117 MAJ-2118 MAJ-2114 MAJ-2330 MAJ-2115 MD-493 BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D FB-231D BF-H1100 BF-P190 BF-XP190 BF-1TH1100 BF-XT190 OTV-SP1H-NA-12E OTV-S7H-1NA-12Q OTV-S7H-1NA-10E OTV-S7H-VA OTV-S7PROH-HD-12Q OTV-S7H-N OTV-S7H-1NA-12E OTV-S7H-NA-12E OTV-S7H-1NA OTV-S7H-NA 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 SIF-Q180 MAJ-1970 MAJ-1545 MAJ-1508 MAJ-1498 MAJ-2131 MAJ-1504 MAJ-1969 MAJ-1517 MAJ-2124 MAJ-1512 MAJ-1505 MAJ-1764 MAJ-1971 MAJ-1503 MAJ-1546

    Establishment Types

    Manufacture Medical Device