BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    sempermed velvet (100)

    Reg #: 3010605427 · FEI: 3010605427 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HARPS Investment Asia Pte. Ltd.
    Registration Number
    3010605427
    FEI Number
    3010605427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Straits View, #08-10A, Marina One West Tower
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K211022

    Owner / Operator

    Firm Name
    HARPS Investment Asia Pte. Ltd.
    Operator Number
    10045460
    Address
    9 Straits View, #08-10A, Marina One West Tower
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    018937
    Country
    SG

    US Agent

    Business Name
    Mansour Consulting LLC
    Contact Name
    Jay Mansour
    Address
    845 Aronson Lake Court
    City
    Roswell
    State
    GA
    ZIP
    30075
    Country
    US
    Email
    [email protected]
    Phone
    678 9088180

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    sempermed velvet (100) CARACAL velvet NBR PF VB 300pc Nitrile SPK-035VB NBR PF VB 6pc SP Semperguard Xpert Semperguard Force+ Nitrile Exam PF 3.5 Essentials Nitrile Exam Care One Nitrile Exam Quality Choice Nitrile Exam Glove DealMed Nitrile Exam (200 count) GlovePak Azurite Nitrile Exam DealMed Nitrile Exam NBR PF VB 100pc StarMed Select Nitrident Comfort+ Touch 200 Nitrile Exam IMCO powder free Nitrile Exam Gloves DealMed Nitrile Exam (100 count) Tender Touch Nitrile PF 100 Gemini Nitrile Exam Nitrident Touch 200 Nitrile Exam DirectSafety Nitrile Light Exam PF DealMed Nitrile Exam (300 count) Tender Touch Nitrile PF 200 Essentials Ultra Nitrile Exam Sempermed Safe Patient Armor Blu Nitrile SPK-030VB NBR PF VB 6pc StarMed ULTRA NITRILE sempermed velvet XP (200) GlovePak Skye Nitrile Exam StarMed PLUS sempermed velvet (300) CareOne Nitrile NBR PF VB DealMed Nitrile Exam NBR PF VB 300pc sempermed velvet XP (250)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device