BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    BIOPSIBLADE

    Reg #: 8031525 · FEI: 6827 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAI INDUSTRIES CO., LTD.
    Registration Number
    8031525
    FEI Number
    6827
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1110 OYANA
    City
    SEKI CITY Gifu
    Country
    JP

    Owner / Operator

    Firm Name
    KAI INDUSTRIES CO., LTD.
    Operator Number
    8031525
    Address
    1110 Oyana
    City
    Seki
    State
    Gifu
    Postal Code
    5013992
    Country
    JP

    US Agent

    Business Name
    KAI USA LTD.
    Contact Name
    Noritaka Sawamura
    Address
    18600 S.W. TETON AVE.
    City
    TUALATIN
    State
    OR
    ZIP
    97062
    Country
    US
    Email
    [email protected]
    Phone
    503 6821966

    Products

    Device Name Product Code
    Scalpel, One-Piece GDX

    Proprietary Names

    BIOPSIBLADE SCALPEL, ONE-PIECE KAI Disposable Mini-Scalepl DISPOSABLE SCALPEL NO.21 DISPOSABLE SAFETY SCALPEL NO.20 COATED DISPOSABLE SCALPEL NO.24 DISPOSABLE SAFETY SCALPEL NO.25 COATED DISPOSABLE SCALPEL NO.20 COATED DISPOSABLE SCALPEL NO.14 COATED DISPOSABLE SCALPEL NO.23 DISPOSABLE SAFETY SCALPEL NO.11 COATED DISPOSABLE SCALPEL NO.15 DISPOSABLE SAFETY SCALPEL NO.15 DISPOSABLE SCALPEL NO.12 COATED DISPOSABLE SCALPEL NO.25 COATED DISPOSABLE SCALPEL NO.12 COATED DISPOSABLE SCALPEL NO.21 COATED DISPOSABLE SCALPEL NO.22 COATED DISPOSABLE SCALPEL NO.11 NON-STERILE, BULK DISPOSABLE MINI-SCALPEL NO.11 - STAINLESS DISPOSABLE SCALPEL NO.15 DISPOSABLE SAFETY SCALPEL NO.24 DISPOSABLE SCALPEL NO.23 DISPOSABLE SCALPEL NO.20 DISPOSABLE SAFETY SCALPEL NO.23 DISPOSABLE SCALPEL NO.24 DISPOSABLE SCALPEL NO.25 DISPOSABLE SAFETY SCALPEL NO.21 DISPOSABLE SCALPEL NO.22 DISPOSABLE SAFETY SCALPEL NO.22 COATED DISPOSABLE SCALPEL NO.10 DISPOSABLE SCALPEL NO.10 DISPOSABLE SAFETY SCALPEL NO.10 DISPOSABLE SAFETY SCALPEL NO.12 DISPOSABLE SCALPEL NO.11

    Establishment Types

    Manufacture Medical Device