BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Sentosa SA201 HSV 1/2 PCR Test

    Reg #: 3009875001 · FEI: 3009875001 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Vela Operations Singapore Pte Ltd
    Registration Number
    3009875001
    FEI Number
    3009875001
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 Science Park Road, #05-07, The Kendall
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K172509

    Owner / Operator

    Firm Name
    Vela Operations Singapore Pte Ltd
    Operator Number
    10041832
    Address
    50 Science Park Road, #05-07
    City
    Singapore
    State
    Central Singapore
    Postal Code
    117406
    Country
    SG
    Correspondent
    Boon King Teh

    US Agent

    Business Name
    Vela Diagnostics
    Contact Name
    Keisha Shaut
    Address
    353c Us Highway 46 Ste 250
    City
    Fairfield
    State
    NJ
    ZIP
    07004
    Country
    US
    Email
    [email protected]
    Phone
    973 3695549

    Products

    Device Name Product Code
    Herpes Simplex Virus Nucleic Acid Amplification Assay OQO

    Proprietary Names

    Sentosa SA201 HSV 1/2 PCR Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device