BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Corporation Medical Systems Research & Development Center Kaisei

    Reg #: 3042225166 · FEI: 3042225166 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    188
    Establishment Types
    4
    Classifications
    30

    Registration Details

    Registration Name
    FUJIFILM Corporation Medical Systems Research & Development Center Kaisei
    Registration Number
    3042225166
    FEI Number
    3042225166
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    577, Ushijima, Kaisei-Machi
    City
    Ashigarakami-Gun Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K251830

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

    Proprietary Names

    Sonosite LX Ultrasound System UHF46-20 Transducer EN-580T TS-12140 Sterile Overtube TS-13101 Sterile Overtube TS-13140 Sterile Overtube Video Laparoscope EL-R740M Endoscope Model EI-740D/S VS-1000 EG-S100XT Over-Tube TS-1314B Tube Kit TY-500D Scope Balloon BS-4 Endoscope Model EN-580T EB-580S Bronchoscope EB-580T Bronchoscope CA-500B Cleaning Adapter Kit for G-5 Bronchoscopes CA-500C Cleaning Adapter Kit CA-500BU Cleaning Adapter Kit for EB-530US Ultrasonic Endoscope EG-580UR Ultrasonic Endoscope EG-580UT FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 Distal Cap Model DH-17EN2 Distal Cap Model DH-32EN Endoscopic Ultrasonic Probe P2620S-L / P2612S-L BS-2 Balloon for DBE FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Ultrasonic Endoscope EB-530US Balloon BS-3 Sonosite MT Ultrasound System Grasping Forceps GF3612RT TRACMOTION EB-710XT Video Bronchoscope EB-530P JT-500 J-Tube EC-740T/L Colonoscope EG-760CT Gastroscope EC-760P-V/L Colonoscope CT-2LT LT-100 CT-1LT Distal End Cap DC-08D 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 FUJIFILM Over-tube TR-1504A FUJIFILM Over-tube TR-1507A DH-126STL DH-116STL DH-106STL DH-096ST 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 Processor VP-7000 Light Source BL-7000X Image Processing Unit EX-0 CC7-402 CC7-502 DK2623JI FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI FUJIFILM Diathermic Slitter (FlushKnife) TR-1108A MPC-P Mouth Piece MPC-ST Mouth Piece Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 FUJIFILM Ultrasonic Endoscope EB-710U Double Balloon Endoscope EN-840T FUJIFILM Processor EP-8000 FUJIFILM Endoscope Model EG-860R B20BU Balloon for EB-530US FOV-BU1 Forceps Valve for EB-530US ED-S100TP ED-580XT Duodenoscope EW10-EC02 Endoscopy Support Program Ultrasonic Probe PB2020-M2 Ultrasonic Processor SP-900 Gas/Water Valve AW-604G Water Tank WT-04G Gas Tube, CT-11G Fujifilm Endoscopic CO2 Regulator GW-100 Water Tank WT-604G DH-094STR DH-114STR DH-084STR DH-124STR DH-104STR DH-134STR FUJIFILM Video Laparoscope Model EL-R740M30 CA-616 Cleaning Adapter FV--003 Forceps Valve SB-606 Suction Valve EB-710P Bronchoscope Endoscope Model EC-760S-V/L Color Balance Tool CB-01P, CB-01B Fujifilm Diathermic Slitter (FlushKnife) Short Double Balloon Endoscope EI-580BT 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 Endoscope Model EG-740N BL-7000 EL-R740S FUJIFILM Endoscope Model EC-760S-A/L Endoscopy Support Program EW10-VM01 EB-530H Bronchoscope SB-602 Suction Button for 530 Series Bronchoscopes (Sterile) FUJIFILM Diathermic Slitter; FlushKnife (DK2618J, DK2623J) and FUJIFILM Diathermic Slitter; ClutchCutter (DP2618DT) Distal Cap Models DH-33GR, DH-34CR, DH-40GR, DH-35GZ, DH-37CZ, DH-38CZ, DH-39CZ B20UT Balloon for EG-530UT Series Ultrasonic Endoscopes B20UR Balloon for EG-530UR Series Ultrasonic Endoscopes CA-601 Cleaning Adapter Kit for Ultrasonic Endoscope DH-083ST EB-840S EB-840T Fujifilm Tubing, Model TY-06D Fujifilm Overtube, TS-13140 Fujifilm Tubing, Model TY-04D Fujifilm Enteroscope EN-580T Remote Switch: RC-30 Balloon Controller: PB-30 BS-102 UC-01 EG-740UT EC-760Z-V/L Colonoscope Fujifilm WT-4 Water Tank FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 FUJIFILM Endoscope Model EC-860P/M FUJIFILM Endoscope Model EC-860S/L FUJIFILM Endoscope Model EC-860P/L Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) DC-07D Distal End Cap FUJIFILM Hood Model DH-29CR FUJIFILM Hood Model DH-30CR FUJIFILM Hood Model DH-28GR

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)