BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    ASAHI INTECC (THAILAND) CO., LTD.

    Reg #: 3003780911 · FEI: 3003780911 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    171
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    ASAHI INTECC (THAILAND) CO., LTD.
    Registration Number
    3003780911
    FEI Number
    3003780911
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    158/1 Moo 5, Bangkadi Idustrial Park, TIWANON ROAD, TAMBOL BANGKADI,
    City
    Amphur Muang Pathumthani Pathum Thani
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K202252

    Owner / Operator

    Firm Name
    ASAHI INTECC CO., LTD.
    Operator Number
    9051916
    Address
    3-100 Akatsuki-cho, --
    City
    Seto
    State
    Aichi
    Postal Code
    489-0071
    Country
    JP

    US Agent

    Business Name
    ASAHI INTECC CO., LTD.
    Contact Name
    Ariel Barrett
    Address
    22 Executive Park, Suite 110
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 7568636

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY
    Catheter, Peripheral, Atherectomy MCW
    Guide, Wire, Catheter, Neurovasculature MOF
    Snare, Flexible FDI
    Electrode, Electrosurgical, Active, Urological FAS

    Proprietary Names

    ASAHI PTCA Guide Wire ASAHI SION black FUBUKI XF Neurovascular Long Sheath ASAHI SION blue Phoenix Atherectomy Catheter, 1.8mm X 149cm Phoenix Atherectomy System, 1.8mm X 149cm Kit Phoenix Atherectomy System, 2.2mm X 149cm Kit Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter, 2.2mm X 149cm VASSALLO GT Support VASSALLO GT Crossing VASSALLO GT Floppy ASAHI Corsair Pro XS CROSSLEAD Tracker VASSALLO GT 018 Floppy Regalia XS Tornus CROSSLEAD Pro 035 ASAHI FUBUKI ASAHI FUBUKI 043 CROSSLEAD Pro 014 Miracle bros Confianza Pro Asahi Soft Miraclebros Prowater Grand Slam SION Phoenix Atherectomy Catheter, 1.8mm X 130cm Phoenix Atherectomy System, 1.8mm X 130cm Kit Phoenix Atherectomy System, 2.2mm X 130cm Kit Phoenix Atherectomy Catheter, 2.2mm X 130cm X-treme Fielder Fielder FC Astato XS 20 Astato 30 ASAHI CHIKAI black 14 soft tip MINAMO ASAHI Corsair Armet 135cm ASAHI Corsair Armet 60cm ASAHI Corsair Armet 90cm ASAHI Corsair Armet 150cm ASAHI Corsair Pro 150cm ASAHI Corsair Pro 135cm ASAHI Gladius Mongo 18 PV ES Vassallo GT 018 Hybrid Gladius Mongo 14 Gladius Mongo 14 ES ASAHI Fielder XT-A ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-R 300cm ASAHI SUOH 03 CROSSLEAD Pro 018 Treasure Floppy ASAHI Corsair Armet 18 Astato XS 40 FUBUKI XF-R Neurovascular Long Sheath Corsair Armet SheathLess Eaucath Coronary Guide Catheter ASAHI Tellus C3 ASAHI Tellus ASAHI Veloute ASAHI Veloute C3 SAYA 86 Radial Access Guide Catheter ASAHI Gaia First 300cm ASAHI Gaia Second Pre- shape ASAHI Gaia Second 300cm ASAHI Gaia Third 300cm ASAHI MIRACLEbros 6 300cm ASAHI ULTIMATEbros 3 180cm J ASAHI CONFIANZA PRO 12 180cm ASAHI MIRACLEbros 4.5 180cm ASAHI MIRACLEbros 6 180cm ASAHI FIELDER XT-A 300cm ASAHI MIRACLEbros 12 180cm ASAHI MIRACLEbros 3 180cm ASAHI Gaia Third Pre- shape ASAHI Gaia First ASAHI ULTIMATEbros 3 180cm ASAHI Gaia First 300cm Pre-shape ASAHI CONFIANZA PRO 300cm ASAHI Gaia Second 300cm Pre-shape ASAHI Gaia Third 300cm Pre-shape ASAHI Corsair Pro, 150cm ASAHI Gaia Third ASAHI CONFIANZA PRO 12 300cm ASAHI Corsair Pro, 135cm ASAHI ULTIMATEbros 3 300cm ASAHI FIELDER XT-A 190cm ASAHI Gaia Second ASAHI MIRACLEbros 12 300cm ASAHI FIELDER XT-R 300cm ASAHI FIELDER XT 190cm ASAHI Gaia First Pre- shape ASAHI FIELDER XT-R 190cm ASAHI MIRACLEbros 3 300cm ASAHI MIRACLEbros 4.5 300cm ASAHI CONFIANZA PRO 180cm ASAHI ULTIMATEbros 3 300cm J ASAHI FIELDER XT 300cm P15149K Phoenix Atherectomy System, 1.5mm X 149cm Kit PD24130 Phoenix Atherectomy Catheter, 2.4mm X 130cm PD24130K Phoenix Atherectomy System, 2.4mm X 130cm Kit P15149 Phoenix Atherectomy Catheter, 1.5mm X 149cm ASAHI SASUKE CONFIANZA PRO Prowater J Prowaterflex J Grand Slam J Confianza Pro J Miraclebros J Asahi Soft J Routreme J PD22130K Phoenix Atherectomy System, 2.2mm X 130cm Kit PD22130 Phoenix Atherectomy Catheter, 2.2mm X 130cm ASAHI RG3 Soft ASAHI RG3 CHIKAI ASAHI Gaia Next 1 ASAHI Gaia Next 2 ASAHI Gaia Next 3 ULTIMATEbros ASAHI Caravel ASAHI Gladius ASAHI Halberd ASAHI Gaia PV ASAHI SION Fielder J VASSALLO GT Crossing 14 Treasure CONFIANZA PRO 8-20 VASSALLO GT 018 G12 VASSALLO GT 018 G30 SION blue PLUS CROSSLEAD Penetration Peripheral Guide Wire ASAHI Gaia Prowaterflex Routreme MINAMO blue MINAMO viola PROWATER ASAHI Gladius18 MIRACLEBROS 3 Treasure 12 MIRACLEBROS 6 ULTIMATEbros 3 ASAHI Gaia PV18 PROWATERflex FIELDER FIELDER XT SOFT GRAND SLAM CONFIANZA PRO 12 MIRACLEBROS 12 EXTENSION FIELDER XT-A FIELDER FC Astato XS40 Regalia XS 1 FIELDER XT-R Halberd18 Miracle 6 Miraclebros 6 Rinato Miraclebros 3 Miracle 3 Branchor Balloon Guide Catheter Branchor X Balloon Guide Catheter VASSALLO GT Hybrid VASSALLO GT EXT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility