BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    YTY ACHEH

    Reg #: 3014847584 · FEI: 3014847584 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    YTY ACHEH
    Registration Number
    3014847584
    FEI Number
    3014847584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 15651, Kawasan Perindustrian Kampung Acheh
    City
    Sitiawan Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K101596

    Owner / Operator

    Firm Name
    YTY Acheh
    Operator Number
    10058255
    Address
    Lot 15651, Kawasan Perindustrian Kampung Acheh
    City
    Sitawan
    State
    Perak
    Postal Code
    32000
    Country
    MY
    Correspondent
    Punitha Samy

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ

    Proprietary Names

    Purple 9.5

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device