BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    LeadtekBiomed Inc.

    Reg #: 3010071455 · FEI: 3010071455 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LeadtekBiomed Inc.
    Registration Number
    3010071455
    FEI Number
    3010071455
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, No. 4 , Alley 11, Lane 327, Sec. 2, Chung San Rd., Chung Ho Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K193350

    Owner / Operator

    Firm Name
    LeadtekBiomed Inc.
    Operator Number
    10095207
    Address
    18F, No.166, Jian 1st Rd., Zhonghe Dist.
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    235
    Country
    TW
    Correspondent
    Terry Kuan

    Products

    Device Name Product Code
    Oximeter DQA
    Adhesive Backed Thermal Skin Patches OMW

    Proprietary Names

    Alvital LeadtekBiomed amor BtNPN Patch

    Establishment Types

    Manufacture Medical Device