BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Healthcare Manufacturing Corporation Sano Office

    Reg #: 3006161756 · FEI: 3002808127 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    167
    Establishment Types
    2
    Classifications
    26

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation Sano Office
    Registration Number
    3006161756
    FEI Number
    3002808127
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    700 Konaka-Cho
    City
    Sano City Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K243260

    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
    Gastroscope And Accessories, Flexible/Rigid FDS
    Led Light Source NTN
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Forceps, Biopsy, Electric KGE
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Bite Block MNK
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Colonoscope And Accessories, Flexible/Rigid FDF
    Enteroscope And Accessories FDA
    Bronchoscope (Flexible Or Rigid) EOQ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Laparoscopic Accessories, Gynecologic NWV
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Forceps, Biopsy, Non-Electric FCL
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Endoscopic Light-Projecting Measuring Device QTH
    Laparoscope, General & Plastic Surgery GCJ
    Tubes, Gastrointestinal (And Accessories) KNT
    Oximeter, Tissue Saturation MUD
    Accessories, Cleaning Brushes, For Endoscope MNL

    Proprietary Names

    FUJIFILM Processor EP-8000 FUJIFILM Endoscope Model EG-860R Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) Endoscopic Ultrasonic Probe P2620S-L / P2612S-L MPC-P Mouth Piece MPC-ST Mouth Piece Fujifilm Diathermic Slitter (FlushKnife) Endoscope Model EI-740D/S EC-740T/L Colonoscope EG-760CT Gastroscope EC-760P-V/L Colonoscope Double Balloon Endoscope EN-840T CA-616 Cleaning Adapter FV--003 Forceps Valve SB-606 Suction Valve EB-710P Bronchoscope FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Color Balance Tool CB-01P, CB-01B Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 ED-580XT Duodenoscope BS-102 UC-01 EG-740UT B20BU Balloon for EB-530US FOV-BU1 Forceps Valve for EB-530US CA-500B Cleaning Adapter Kit for G-5 Bronchoscopes CA-500C Cleaning Adapter Kit CA-500BU Cleaning Adapter Kit for EB-530US DC-07D Distal End Cap Fujifilm Tubing, Model TY-06D Fujifilm Overtube, TS-13140 Fujifilm Tubing, Model TY-04D Fujifilm Enteroscope EN-580T FUJIFILM Hood Model DH-29CR FUJIFILM Hood Model DH-30CR FUJIFILM Hood Model DH-28GR 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 EB-530H Bronchoscope SB-602 Suction Button for 530 Series Bronchoscopes (Sterile) Endoscope Model EC-760S-V/L EB-710XT Ultrasonic Endoscope EB-530US Ultrasonic Endoscope EG-580UR Ultrasonic Endoscope EG-580UT FUJIFILM Ultrasonic Endoscope EB-710U VS-1000 EG-S100XT Over-Tube TS-1314B Tube Kit TY-500D Scope Balloon BS-4 Endoscope Model EN-580T TR-1108A EN-580T DH-094STR DH-114STR DH-084STR DH-124STR DH-104STR DH-134STR Endoscope Model EG-740N Video Bronchoscope EB-530P Distal Cap Model DH-17EN2 Distal Cap Model DH-32EN Balloon BS-3 FUJIFILM Over-tube TR-1504A FUJIFILM Over-tube TR-1507A B20UT Balloon for EG-530UT Series Ultrasonic Endoscopes B20UR Balloon for EG-530UR Series Ultrasonic Endoscopes CA-601 Cleaning Adapter Kit for Ultrasonic Endoscope EB-840S EB-840T EB-580S Bronchoscope EB-580T Bronchoscope DK2623JI FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI FUJIFILM Diathermic Slitter (FlushKnife) TS-12140 Sterile Overtube TS-13101 Sterile Overtube TS-13140 Sterile Overtube JT-500 J-Tube Ultrasonic Probe PB2020-M2 Ultrasonic Processor SP-900 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 DH-083ST FUJIFILM Diathermic Slitter; FlushKnife (DK2618J, DK2623J) and FUJIFILM Diathermic Slitter; ClutchCutter (DP2618DT) ED-S100TP Short Double Balloon Endoscope EI-580BT FUJIFILM Endoscope Model EC-760S-A/L Endoscopy Support Program EW10-VM01 FUJIFILM Endoscope Model EC-860P/M FUJIFILM Endoscope Model EC-860S/L FUJIFILM Endoscope Model EC-860P/L BL-7000 EL-R740S BS-2 Balloon for DBE FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 Processor VP-7000 Light Source BL-7000X Image Processing Unit EX-0 CC7-402 CC7-502 EC-760Z-V/L Colonoscope WB4321FW2 Washing Brush / 4.3mm/2100mm WB11001FW2 Valve Cylinder Washing Brush / 11mm/100mm WB1318DE Single Use Cleaning Brush for Endoscope WB4324FW2 Washing Brush for EN-580T Endoscope WB11003DV Valve Cleaning Brush / 8 to 11mm/63mm WB11002FW2 Valve Cylinder Washing Brush / 11mm/200mm WB7025DC Channel Cleaning Brush / 5.9 to 8mm/2500mm WB2517DC Balloon Channel Cleaning Brush WB3503FW Washing Brush / 3.5mm/300mm WB3512FW Washing Brush / 3.5mm/1200mm WB3212FW2 Washing Brush / 3.2mm/1200mm WB2212FW2 Washing Brush / 2.2/1200mm WB2221FW2 Jet Port Washing Brush for 200/400 Series Endoscopes WB3225DS Washing Brush / 3.5mm/1200mm WB5021FW2 Washing Brush / 5mm/2100mm WB4325DS Washing Brush / 3.5mm/1200mm WB3218FW2 Washing Brush / 3.2mm/1800mm DH-126STL DH-116STL DH-106STL DH-096ST

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)