BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    BioSieve Multi-Drugs Using Test Cup

    Reg #: 3038614708 · FEI: 3038614708 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    PT. JAYAMAS MEDICA INDUSTRI TBK
    Registration Number
    3038614708
    FEI Number
    3038614708
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dusun Karangmenjangan, Desa Karangwinongan, Kec. Mojoagung, Kab.
    City
    Jombang Jawa Timur
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K222667

    Owner / Operator

    Firm Name
    PT. JAYAMAS MEDICA INDUSTRI TBK
    Operator Number
    10093542
    Address
    Dusun Karangmenjangan, Desa Karangwinongan, Kec. Mojoagung, Kab.
    City
    Jombang
    State
    Jawa Timur
    Postal Code
    61482
    Country
    ID
    Correspondent
    William Slevin

    US Agent

    Business Name
    medapproval llc
    Contact Name
    william slevin
    Address
    11555 Medlock Bridge Rd Ste 100
    City
    Johns Creek
    State
    GA
    ZIP
    30097
    Country
    US
    Email
    [email protected]
    Phone
    404 5935005

    Products

    Device Name Product Code
    Test, Methadone, Over The Counter PTG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Cannabinoid, Over The Counter NFW
    Test, Opiates, Over The Counter NGL
    Test, Methamphetamine, Over The Counter NGG
    Test, Amphetamine, Over The Counter NFT
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Barbiturate, Over The Counter PTH
    Test, Propoxyphene, Over The Counter QBF
    Test, Benzodiazepine, Over The Counter NFV

    Proprietary Names

    BioSieve Multi-Drugs Using Test Cup BioSieve Multi Drigs Urine Test Cup

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)