BEUDAMED
    FDA Registration Active 🇱🇰 Sri Lanka

    PI Hybrid Micro

    Reg #: 8041180 · FEI: 3002806389 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ANSELL LANKA (PVT.), LTD.
    Registration Number
    8041180
    FEI Number
    3002806389
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BIYAGAMA EXPORT PROCESSING, ZONE,
    City
    BIYAGAMA Gampaha
    Country
    LK

    Regulatory Submissions

    510(k) Number
    K231902

    Owner / Operator

    Firm Name
    ANSELL HEALTHCARE PRODUCTS LLC
    Operator Number
    8020065
    Address
    2301 Robb Drive
    City
    Reno
    State
    NV
    Postal Code
    89523
    Country
    US

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Surgeon'S Gloves KGO

    Proprietary Names

    PI Hybrid Micro

    Establishment Types

    Manufacture Medical Device