BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    OSSAWARE BIOTECH CO., LTD.

    Reg #: 3013340866 · FEI: 3013340866 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSSAWARE BIOTECH CO., LTD.
    Registration Number
    3013340866
    FEI Number
    3013340866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 51, Xinggong Rd.,
    City
    Shenkang Hsiang Changhua
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K192310

    Owner / Operator

    Firm Name
    OSSAWARE BIOTECH CO., LTD.
    Operator Number
    10075919
    Address
    No. 51, Xinggong Rd.,
    City
    Shenkang Hsiang
    State
    Changhua
    Postal Code
    50971
    Country
    TW
    Correspondent
    Meng Feng Huang

    US Agent

    Business Name
    Cusmed Biotech LLC
    Contact Name
    JJ Wu
    Address
    7582 Las Vegas Blvd S #650
    City
    Las Vegas
    State
    NV
    ZIP
    89123
    Country
    US
    Email
    [email protected]
    Phone
    702 6133699

    Products

    Device Name Product Code
    Accessory, Surgical Apparel LYU
    Cover, Burr Hole GXR

    Proprietary Names

    CUSMED FACE MASK 9900103.16S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D16mm, Sterile 9901001.15S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile 9900101.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile 9904101.15S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile 9901103.16S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D16mm, Sterile 9901003.16S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D16mm, Sterile 9903001.15S connectCMF connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile 9900102.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile 9904103.16S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D16mm, Sterile 9901104.22S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile 9900004.22S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D22mm, Sterile 9906014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver for Shunt & ICP, PEEK, 14mm/11mm, Sterile 99050118S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 11mm/8mm, Sterile 9903102.20S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D20mm, Sterile 9900003.16S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D16mm, Sterile 9904001.15S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile 99050139S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 13mm/9mm, Sterile 9904004.22S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile 9904102.20S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile 99050117S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 11mm/7mm, Sterile 9905014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile 9903103.16S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D16mm, Sterile 9901102.20S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile 9900001.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile 9901101.15S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile 9900002.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile 9904002.20S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile 9904104.22S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile 9903101.15S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile 9903002.20S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D20mm, Sterile 9901004.22S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile 9903003.16S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D16mm, Sterile 9903104.22S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D22mm, Sterile 9900104.22S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D22mm, Sterile 9903004.22S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D22mm, Sterile 9901002.20S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile 9904003.16S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D16mm, Sterile

    Establishment Types

    Manufacture Medical Device