BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SYNOPEX BIOFILTER

    Reg #: 3017676140 · FEI: 3017676140 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    25
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    SYNOPEX BIOFILTER
    Registration Number
    3017676140
    FEI Number
    3017676140
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    54-42, Dongtanhana 1-gil
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Owner / Operator

    Firm Name
    SYNOPEX BIOFILTER
    Operator Number
    10078178
    Address
    54-42, Dongtanhana 1-gil
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18423
    Country
    KR
    Correspondent
    Ha-Na Lee

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) JRS

    Proprietary Names

    SYNOTEX MASK (White) SYNOPEX ABSOLUTE MB MASK (Pink) SYNOPEX ABSOLUTE MB MASK (White) SYNOTEX MASK (Dark Gray) SYNOTEX MASK (Beige) SYNOTEX MASK (Pink) SYNOPEX ABSOLUTE MB MASK (Beige) SYNOPEX ABSOLUTE MB MASK (Light Pink) SYNOTEX MASK (Black) SYNOPEX ABSOLUTE MB MASK (Khaki) SYNOPEX ABSOLUTE MB MASK (Light Gray) SYNOTEX MASK (Light Gray) SYNOTEX MASK (Light Pink) SYNOPEX ABSOLUTE MB MASK (Black) SYNOPEX ABSOLUTE MB MASK (Dark Gray) Absolute Water Purifier(PRO)(Black) Absolute Water Filter for Purifier(max)(Black) Absolute Water Purifier(MAX)(Black) Absolute Water Purifier(PRO)(White) Absolute Water Filter for Purifier(pro)(White) Absolute Water Filter for Purifier(pro)(Black) Absolute Water Filter for Purifier(head)(White) Absolute Water Purifier(MAX)(White) Absolute Water Filter for Purifier(max)(White) Absolute Water Filter for Purifier(head)(Black)

    Establishment Types

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