BEUDAMED
    FDA Registration Active 🇨🇳 China

    SANHE MEDITECH CO., LTD

    Reg #: 3027851853 · FEI: 3027851853 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SANHE MEDITECH CO., LTD
    Registration Number
    3027851853
    FEI Number
    3027851853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 3, Building 15, Zhongnan High Tech, No.4 Liushan Street, Yanjiao
    City
    Sanhe Hebei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K260257

    Owner / Operator

    Firm Name
    Sanhe Meditech Co., Ltd
    Operator Number
    10088569
    Address
    Unit 3, Building 15, Zhongnan High Tech, No.4 Liushan Street, Yanjiao
    City
    Sanhe
    State
    Hebei
    Postal Code
    065201
    Country
    CN
    Correspondent
    Xiaoxia Song

    US Agent

    Business Name
    BTS US Inc
    Contact Name
    Alex Gary
    Address
    1624 Market St
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    844 9823583

    Products

    Device Name Product Code
    Gas, Laser Generating NXF
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Diode Laser Hair Removal Machine: GLD21, GLD25, GLD26 Picosecond Laser Machine: GL018, GL019, GL020, GL021, GL022, GL023, GL025, GL026, GL027, GL029 Facial Beauty Machine: GL001, GL002, GL003, GL005, GL006, GL007, GL008, GL009, GL010, GL012, GL015, GLY01, GLY02, GLY03 Diode Laser Hair Removal Machine: GLD05, GLD06, GLD07, GLD08,GLD15, GLD17, GLD18 Plasma Laser Beauty Machine: GL017 Facial Beauty Machine: GLC01, GLC02, GLC03, GLC05, GLC16, GLQ01, GLQ02, GLQ03, GLP03 Air Cooling Machine : GLD12 Picosecond Laser Machine: GL031, GL032, GL035, GL040 CO2 Laser Machine: GL063,GL070, GL080, GL090 CO2 Laser System:GL060, GL062, GL065, GL066, GL067, GL068 Nd YAG Laser Therapy Systems:GL022,GL028,GL030,GL036,GL037, GL038,GL039 Diode Laser Hair removal Machine: GLD01, GLD10, GLD16,GLD02,GLD03,GLD09,GLD19,GLD20,GLD22,GLD23

    Establishment Types

    Manufacture Medical Device