BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    HEBEI MITA BIOTECHNOLOGY LIMITED

    Reg #: 3043011436 · FEI: 3043011436 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    60
    Establishment Types
    2
    Classifications
    16

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    Registration Details

    Registration Name
    HEBEI MITA BIOTECHNOLOGY LIMITED
    Registration Number
    3043011436
    FEI Number
    3043011436
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K241860

    Owner / Operator

    Firm Name
    HEBEI MITA BIOTECHNOLOGY LIMITED
    Operator Number
    10094693
    Address
    Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Shujuan Zhao

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Gas, Laser Generating NXF
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers PZL
    Powered Surgical Instrument For Improvement In The Appearance Of Cellulite OUP
    Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase DLI
    Colonic Irrigation System KPL
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Unit, Syringe, Air And/Or Water ECB
    Powered Laser Surgical Instrument GEX
    Stimulator, Muscle, Powered IPF
    Laser, Comb, Hair OAP
    Marker, Skin FZZ
    Unit, Heating, Powered IRQ
    Guide, Needle, Surgical GDF
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    OMG199,OMG198,OMG211,OMG217,OMG219,HF001,HF002,HF003,HF004,HF005,OMG193,HF006,HF0022,HF0017,HF0021,HF0026,HF007, High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,OMG114, HF0038,HF0039,HF0040,HF0041,HF0042,HF0043 HF0024,HF0025,AGF65,HF0028,HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037, HF008,HF0023,HF009,HF0010,HF0011,HF0012,HF0013,HF0014,OMG135,HF0016,HF0018,HF0019,HF0020, OMG131,OMG165,OMG210,OMG166,OMG167,OMG177,OMG191,OMG206,HF0030,OMG207, PM029, PM033, PM034, PM035, PM036, PM037, PM038, JXY-PM001, JXY-PM0012, XOM-PM001, XOM-PM002 Picosecond Laser Machine:OMG30, OMG172, PM001, PM002, PM003, PM004, PM005, PM006, PM007, PM008, PM009, PM011, PM012, PM015, PM016, PM017, PM022, PM023, PM024, PM025, PM026, PM028, Multi-functional 980 1470 Diode Laser Machine:LLY006, LLY007, LLY008 ,LLY0030,LLY0043, OM213 Shockwave therapy:AG213,AGF66,AME25,MT07,MT08,OM213,OMG87,OMG110,OMG111,OMG119,OMG157, OMG192,OMG208,OMG212,OMG221,JXY-CJB001,XOM-LLY001,XOM-LLY002,YTL-CJB001 LD22,LD263,OMG37,LD24,LD25,LD26,LD27,LD28,LD29,LD30 Multi-functional Cryolipolysis Slimming System:OMG09,OMG26,OMF72,OME57,OM253,OMF72,OMF76,OME78,OMG105,OMC86,OM173,OMD35, OMG126,OMG176,OMG184,OMG185,OMG186,OMG187,OMG188,LD015,OMG200,OMG202, OMG216,LD005,LD006,LD007,LD009,LD010,LD11,LD12,LD013,LD014,LD016,LD017,LD018,LD19,LD20, OMG17,OMG36,OMG45,OMG47,OMG74,OMG80,OMG83,OMG109,OMG112,OMG113,OMG90, DZ019, DZ010, DZ021, DZ027, DZ030, DZ031, DZ032, DZ033, DZ034, DZ035, DZ036, DZ037 Fractional CO2 Laser System Machine:AGF80, AME85, DZ001, DZ008, DZ009, DZ010, DZ012, DZ013, DZ014, DZ015, DZ016, DZ018, Colon hydrotherapy machine:YL001,YL002,YL003,YL004,YL005,YL006,YL007 CLS0017,CLS0018,CLS0019,CLS0021,CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038 Muscle Stimulation EMS Sculpting Machines:AME83,KSH64,OMG127,OMG128,OMG129,OMG174, OMG150,OMG-PST001,D03,OMD76,OM167,OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149, CO2 ELECTRONIC MUSCLE STIMULATOR JXY-TMY002, JXY-TMY003, JXY-TMY004, JXY-TMY005, XOM-TMY001, XOM-TMY002, XOM-TMY003 Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138, OMG178, TMY036, TMY037, TMY038, TMY039, TMY040, TMY041, TMY042, TMY043, TMY044, JXY-TMY001, TMY026, TMY027, TMY028, TMY029, TMY030, TMY031, TMY032, TMY033, TMY034, TMY035, TMY011, TMY012, TMY013, TMY014, TMY015, TMY016, TMY017, TMY018, TMY019, TMY020, TMY021, TMY022, TMY023, TMY024, TMY025, OMG179, OMG181, OMG214, OMG218, TMY001, TMY002, TMY003, TMY004, TMY005, TMY006, TMY007, TMY008, TMY009, TMY010, Hair Regrowth Machine:OMG118,OMG153,SFY001,SFY002,SFY003,SFY004,YTL-SFY005 Diode Laser Hair Removal System Skin analyzer machine:KSH75,PFFX001,PFFX002,PFFX005,OM26,PFFX005,PFFX008,PFFX0011,PFFX0014 Spa capsule:AGF74,AM226,KS43,OMG125 Hyperbaric oxygen chamber:GY001,GY002,GY003,GY004,GY005,GY006 Facial Spa Oxygen Hydro Facial Beauty System:AG51,AG154,AGF04,AGF54,AGF55,AGF68,AMB53,Keysun160,ksh75,Omd85,Omg25,Omg57, Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016 Omg205,Omg209,Omg213,Omg215,JXY-SYY001,JXY-SYY002,JXY-SYY003,JXY-SYY004, Omg68,Omg69,Omg89,Omg99,Omg120,Omg139,Omg140,Omg142,Omg158,Omg170,Omg197,Omg203, JXY-SYY005,JXY-SYY006,JXY-SYY007, XOM-SYY001,YTL-SYY001,YTL-SYY002,YTL-SYY003 Hyperbaric Oxygen Chamber:OMG-TKC009,OMG-TCK011,JXY-GYYC001 BZY030,BZY031,BZY032,BZY033,BZY034 OMG194,OMG195,OMG196,OMG201,OMG220,BZY001,BZY002,BZY003,BZY004,BZY004,BZY005, RF Cavitation machine:AGF67,AMB97,OM63,OMG16,OMG16,OMG75,OMG85,OMG97,OMG122,OMG123,OMG124,OMG133, BZY018,BZY019,BZY020,BZY021,BZY022,BZY023,BZY024,BZY025,BZY026,BZY027,BZY028,BZY029, BZY006,BZY007,BZY008,BZY009,BZY010,BZY011,BZY012,BZY013,BZY014,BZY015,BZY016,BZY017, WZ0011,WZ0012,WZ0013,WZ0014,WZ0015,WZ0016,WZ0017,WZ0018,WZ19,WZ0020,WZ0021,WZ0022, OMG168,OMG207,WZ001,WZ002,WZ003,WZ005,WZ009,WZ006,WZ007,WZ008,WZ009,WZ0010, Rf Microneedling Machine:OMH61,MT01,MT02,MT04,MT06,MT09,WZ004,MT03,OM214,OMG71,OMD83,OMG53,OMG141, WZ0023,WZ0026,WZ0025,WZ0026,WZ0027,WZ00028,WZ0029,WZ0030 Laser slimming machine:OMG103, OMG115, OMG152, OMG169, JGJF001, JGJF002, JGJF003, JGJF004, JGJF005, SPA Chair/Bed:MRC001,MRC002,MRC003,MRC004,MRC005,MRC006,MRC007,MRC008,MRC009 Vela Shape machine:WL001,WL002,WL003,WL004,WL005,WL006,WL007,WL008,WL009,WL010,WL011,WL012,WL013, JGJF006, JGJF007, JGJF008, JGJF009, JGJF0010, JGJF0011, JGJF0012, JGJF0013, JGJF0014, LZB014,LZB015,LZB016,LZB017,LZB018,LZB019,LZB020,LZB021 Plasma Beauty Device:LZB001,LZB002,LZB003,LZB004,LZB005,LZB006,LZB007,LZB008,LZB009,LZB010,LZB011,LZB012,LZB013, WL014,WL015,WL016.WL017,WL018,WL019,WL020 JGJF0015, JGJF0016, JGJF0017, JGJF0018, JXY-JGJF001, XOM-JGJF001, XOM-JGJF002

    Establishment Types

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