BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    KY Intense

    Reg #: 3003071219 · FEI: 3003071219 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SSL MANUFACTURING (THAILAND) LTD.
    Registration Number
    3003071219
    FEI Number
    3003071219
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WELLGROW INDUSTRIAL ESTATE, 100 MOO 5, BANGNA-TRAD KM 36
    City
    BANGSAMAK,BANGPAKONG Chachoengsao
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K040185

    Owner / Operator

    Firm Name
    RB Health (US) LLC
    Operator Number
    9004884
    Address
    399 Interpace Parkway
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US
    Correspondent
    Andrew - Alum

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    KY Intense Durex Extra Sensitive Stimulating Durex Adventure Pack Durex Pleasure Pack

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility