BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Hystero-V

    Reg #: 3007127244 · FEI: 3007127244 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TAIWAN ADVANCED STERILIZATION TECHNOLOGY INC.
    Registration Number
    3007127244
    FEI Number
    3007127244
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Taichung Export Processing Zone, No. 17-1 Chien Kuo Rd. Tan Tze
    City
    Taichung County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K202445

    Owner / Operator

    Firm Name
    Taiwan Advanced Sterilization Technology Inc.
    Operator Number
    10026550
    Address
    Taichung Export Processing Zone, #17-1 Chien Kuo Rd. Tan Tze
    City
    Taichung County
    State
    TW-TXG
    Postal Code
    427
    Country
    TW
    Correspondent
    Jack Wu

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    Hystero-V

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)