BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Sterilization Pouches / Sterilization Rolls

    Reg #: 3038138452 · FEI: 3038138452 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SAFESECURE MEDICAL INFECTION CONTROL PTE.
    Registration Number
    3038138452
    FEI Number
    3038138452
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 KAKI BUKIT AVENUE 4, #08-32, PREMIER @ KAKI BUKIT
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K242839

    Owner / Operator

    Firm Name
    SAFESECURE MEDICAL INFECTION CONTROL PTE.
    Operator Number
    10092731
    Address
    8 KAKI BUKIT AVENUE 4, #08-32, PREMIER @ KAKI BUKIT
    City
    SINGAPORE
    State
    South East
    Postal Code
    415875
    Country
    SG
    Correspondent
    Parker Lee

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    LEEYEO KEE
    Address
    19 Holly Cove Ln
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Wrap, Sterilization FRG

    Proprietary Names

    Sterilization Pouches / Sterilization Rolls

    Establishment Types

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