BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OKRA Pro

    Reg #: 3020885868 · FEI: 3020885868 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OSANG LLC
    Registration Number
    3020885868
    FEI Number
    3020885868
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    625 Fair Oaks Ave Ste 360
    City
    S Pasadena
    State
    CA
    ZIP
    91030
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182286

    Owner / Operator

    Firm Name
    OSANG HEALTHCARE CO., LTD.
    Operator Number
    9056376
    Address
    132, Anyangcheondong-ro, Dongan-gu
    City
    Anyang
    State
    Gyeonggi
    Postal Code
    14040
    Country
    KR

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    OKRA Pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility