BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PREMIER MEDICAL USA CORPORATION

    Reg #: 3017013438 · FEI: 3017013438 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    PREMIER MEDICAL USA CORPORATION
    Registration Number
    3017013438
    FEI Number
    3017013438
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    27 Schoolhouse Rd
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US

    Owner / Operator

    Firm Name
    Premier Medical USA Corporation
    Operator Number
    10080215
    Address
    27 Schoolhouse Rd
    City
    Somerset
    State
    NJ
    Postal Code
    08873
    Country
    US
    Correspondent
    Matthew Soens

    Products

    Device Name Product Code
    Test, Syphilis, Treponemal MTN
    Test, Hiv Detection MZF
    System, Identification, Hepatitis B Antigen KSJ
    Plasmodium Spp. Detection Reagents OAX
    Dengue Virus Antigen Assay QCU
    Assay, Genotyping, Hepatitis C Virus OBF
    Reagent, Leishmanii Serological LOO

    Proprietary Names

    Sure Status Syphilis Anti-TP Card Test Sure Status HIV 1+2/ Syphilis Combo Card Test Sure Status HIV-1 Recency Card Test Sure Status HIV 1-2 Card Test Sure Status HBsAg Card Test Sure Status Malaria Antigen Pf/PAN Combo Card Test Sure Status Dengue (NS1) Card Test Sure Status HCV Card Test Sure Status Chagas Antibody Card Test

    Establishment Types

    Manufacture Device in the United States for Export Only