BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    FORTUNE MEDICAL INSTRUMENT CORP.

    Reg #: 8022978 · FEI: 3006582718 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    27

    Registration Details

    Registration Name
    FORTUNE MEDICAL INSTRUMENT CORP.
    Registration Number
    8022978
    FEI Number
    3006582718
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 256, Changchun 2nd Rd., Jhongli Dist.
    City
    Taoyuan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K021142

    Owner / Operator

    Firm Name
    FORTUNE MEDICAL INSTRUMENT CORP.
    Operator Number
    8022978
    Address
    6 F., No. 29, Sec. 2, Jhongjheng E. Rd.,, Danshuei Dist,
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    251
    Country
    TW
    Correspondent
    ABE - WANG

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr Ne
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Catheters, Suction, Tracheobronchial BSY
    Bandage, Liquid, Skin Protectant NEC
    Catheter, Ventricular, General & Plastic Surgery GBS
    Catheter, Retention Type, Balloon EZL
    Catheter, Urological KOD
    Accessories, Catheter KGZ
    Mask, Oxygen BYG
    Airway, Oropharyngeal, Anesthesiology CAE
    Tubes, Gastrointestinal (And Accessories) KNT
    Cannula, Nasal, Oxygen CAT
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Balloon, Epistaxis EMX
    Elastomer, Silicone, For Scar Management MDA
    Silicone Hydrogel For Scar Management PFP
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Solvent, Adhesive Tape KOX
    Catheter, Suprapubic (And Accessories) KOB
    Connector, Catheter GCD
    Extractor, Vacuum, Fetal HDB
    Catheter, Multiple Lumen GBP
    Topical Approximation System MZR
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Snare, Surgical GAE
    Tubing, Pressure And Accessories BYX
    Catheter, Peritoneal GBW
    Catheter, Urethral GBM
    Protector, Ostomy EXE

    Proprietary Names

    SILICONE SUCTION CATHETER Rystora® Skin Protector-Spray ALL SILICONE THORA "Fortune" Silicone Hematuria Catheter MEDICAL TUBE Silicone airway (laryngeal) Silicone Nasal Cannula SILICONE C.W.V. RESERVIOR Flexi-Seal® SIGNAL™ Fecal Management System Flexi-Seal Signal FMS Silicone Nasal Epistaxis Balloon Rystora® Silicone Scar Tape Rystora® Silicone Scar Sheet Rystora® Silicone Scar Gel SILICONE T T-Y DRAINAGE TUBE Y Rystora® Adhesive Remover- Spray ALL SILICONE SUPRAPUBIC CATHETER Flexi-Seal Signal FMS Zeolite DRAIN TUBE SILICONE VACUUM SUCTION SILICONE DRAIN CATHETER "Fortune" FixPad Silicone Vessel ID Loops OXYGEN TUBING STOMACH (GASTRIC) TUBING ALL SILICONE PERITONEAL CATHETER SILICONE FOLEY CATHETER FLEXI-SEAL PROTECT PLUS FMS WITH ENFIT CONNECTOR; FLEXI-SEAL PROTECT PLUS FMS WITH LUER CONNECTOR Stoma Protective Powder

    Establishment Types

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