BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office

    Reg #: 3003775006 · FEI: 3003775006 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    126
    Establishment Types
    2
    Classifications
    25

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office
    Registration Number
    3003775006
    FEI Number
    3003775006
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-1-3 KITAYUGUCHI
    City
    HANAMAKI-SHI Iwate
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K192932
    PMA Number
    P160031

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Digital Breast Tomosynthesis OTE
    System, X-Ray, Mobile IZL
    Laparoscope, General & Plastic Surgery GCJ
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Enteroscope And Accessories FDA
    Colonoscope And Accessories, Flexible/Rigid FDF
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    System, X-Ray, Mammographic IZH
    Full Field Digital, System, X-Ray, Mammographic MUE
    Gastroscope And Accessories, Flexible/Rigid FDS
    Instrument, Quality-Assurance, Radiologic LHO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Tomographic IZF
    Bulb, Inflation, For Endoscope FCY
    System, X-Ray, Stationary KPR
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Gastrointesinal Lesion Software Detection System QNP
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Led Light Source NTN
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY

    Proprietary Names

    FDR D-EVO III G35 (DR-ID 1801SE) FDR D-EVO III G43 (DR-ID 1802SE) FDR D-EVO III Flat Panel Detector System (DR-ID 1800) FDR D-EVOIII G35i (DR-ID 1831SE) FDR D-EVOIII C25i (DR-ID 1814SE) FDR D-EVOIII C43i (DR-ID 1812SE) FDR D-EVOIII C35i (DR-ID 1811SE) FDR D-EVOIII G43i (DR-ID 1832SE) FDR D-EVOIII G80i (DR-ID 1836SE) FDR D-EVO II G35 (DR-ID1201SE) FDR D-EVO II G43 (DR-ID1202SE) FDR ES G35 (DR-ID1271SE) FDR D-EVO II (DR-ID1200) FDR D-EVO II Flat Panel Detector System (DR-ID1200) FDR ES C43 (DR-ID1274SE) FDR ES(DR-ID 1270) FDR ES C35 (DR-ID1273SE) FDR ES G43 (DR-ID127SE) FDR D-EVO II C43 (DR-ID 1212SE) FDR D-EVO II C35 (DR-ID 1211SE) FDR D-EVO II C24 (DR-ID 1213SE) FDR ES II C25 DR-ID 1280 DR-ID 1284SE DR-ID 1282SE FDR ES II G43 FDR ES II C35 FDR ES II G35 FDR ES II C43 DR-ID 1283SE DR-ID 1285SE FDR ES II (DR-ID 1280) DR-ID 1281SE FDR D-EVO with X-ray Detection Feature ASPIRE Cristalle Digital Breast Tomosynthesis Option AMULET Innovality Digital Breast Tomosynthesis Option FDR AQRO (DR-XD 1000) FUJIFILM Video Laparoscope Model EL-R740M30 Synapse 3D Base Tools V7 Remote Switch: RC-30 Balloon Controller: PB-30 Gas Tube, CT-11G Water Tank WT-04G Fujifilm Endoscopic CO2 Regulator GW-100 Biopsy Positioner FDR-2000BPY Aspire Cristalle FDR MS-3500 Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 ASPIRE Cristalle DR-ID1200MC FDR D-EVO GL Flat Panel Detector System (DR-ID 1300) FDR D-EVO GL (DR-ID1305SE) DR-ID1300MP Fujifilm WT-4 Water Tank Synapse 3D Base Tools V6.6 Aspire Cristalle (DVIIm) FCR 1 Shot Phantom Plus FDR CROSS (DR-XD 3000) FDR D-EVO Mobile Compo (DR-ID800) Gas/Water Valve AW-604G Water Tank WT-604G DR-ID 1200SDK System FUJIFILM Tomosynthesis Option for FDR AcSelerate Stationary X-ray System CT-2LT LT-100 CT-1LT FUJIFILM FDR Dual Energy Subtraction Option (DES) CP-1TB Trackball Keyboard for Ultrasonic Processors CP-1 Touch-pad Keyboard for Ultrasonic Processors Data Keyboard DK-7000E for VP-7000 and BL-7000 System FS1 Foot Switch for EPX-4440HD EW10-EC02 Endoscopy Support Program BL-7000 EL-R740S Synapse 3D Base Tools (V7.2) Video Laparoscope EL-R740M FCR CARBON XL-2 (CR-IR359) FCR XL-2 (CR-IR359) Fuji IP Cassette Type CC FCR Prima T2 (CR-IR392) FCR PRIMA Tm(CR-IR392) FCR CARBON (CR-IR357) FCR Prima T2(CR-IR392) FCR XC-2 (CR-IR357) FCR Prima T(CR-IR392) KE-007D LT-7F LEAKAGE TESTER AW-603 Air/Water Valve SB-604 Suction Valve LMP-001 LAMP ASSEMBLY FOR EPX-2200 LMP-002 LAMP ASSEMBLY FOR EPX-4400/4400HD FV-001 Forceps Valve FOV-LL2 Forceps Valve for EG-530UT2 CA-617 Cleaning Adapter FV-003 Forceps Valve CA-614 Cleaning Adapter ST-05B Single Use Balloon Applicator for DBE BA-BU1 Balloon Attachment Tool for EB-530US AW-602 Air/Water Valve BA-03 Balloon Attachment Tool WA-7000 US Waterproof Cap FV-002 Forceps Valve CC7-301 Cable FOV-DV7 Disposable Forceps Valve Cover for G-5 Endoscopes ST-01B Black Band Applicator for DBE CA-608 Cleaning Adapter BA-1 Balloon Attachment Tool for EG-530UT2 CA-610 Cleaning Adapter AW-500 A-W BUTTON FOR G-5 SCOPES CA-606 Balloon Channel Cleaning Adapter for EN-580T CA-601 Cleaning Adapter Kit for EG-530UR2/UT2 CA-503/A Cleaning Adapter Kit for G-5 Endoscopes ST-10 Setting Tool CA-611 Air/Water Channel Cleaning Adapter CA-510/A Cleaning Adapter Kit /530 Series Endoscopes CA-503B/C Forceps Inlet Cleaning Adapter for G-5 Endoscopes AW-601 Air/Water Button for Ultrasonic Endoscope CA-609 Air/Water Channel Cleaning Adapter SB-605 Suction Valve SB-500 Suction Button for G-5 Scopes SB-601 Suction Button for Ultrasonic Endoscope FCR PRIMA Tm (CR-IR392) Aspire CRm (CR-IR359)

    Establishment Types

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