BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI SIGMA HIGH-TECH CO., LTD.

    Reg #: 3023306694 · FEI: 3023306694 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI SIGMA HIGH-TECH CO., LTD.
    Registration Number
    3023306694
    FEI Number
    3023306694
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    The West Wing 1st FL, Building No.7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242908

    Owner / Operator

    Firm Name
    Shanghai SIGMA High-tech Co., Ltd.
    Operator Number
    10094696
    Address
    The West Wing1st FL, Building No7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201702
    Country
    CN
    Correspondent
    Xing Guo

    US Agent

    Business Name
    LLINS TECHNOLOGY INC
    Contact Name
    James Wang
    Address
    1312 17th street Unit #2199 Denver, Colorado, 80202, UNITED STATES
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    720 2171916

    Products

    Device Name Product Code
    Light, Ultraviolet, Dermatological FTC

    Proprietary Names

    UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD);

    Establishment Types

    Manufacture Medical Device