BEUDAMED
    FDA Registration Active 🇨🇳 China

    BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD.

    Reg #: 3014388884 · FEI: 3014388884 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    48
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD.
    Registration Number
    3014388884
    FEI Number
    3014388884
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 4009, Building 4, Zhongke Jingwei Industrial Park, No. 8 Yongchang Middle Road, Economic and Technological Development Zone,
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193477

    Owner / Operator

    Firm Name
    Beijing Sea Heart International Science And Technology Co.,L
    Operator Number
    10062040
    Address
    Room 4009, Building 4, Zhongke Jingwei Industrial Park, No. 8 Yongchang Middle Road, Economic and Technological Development Zone,
    City
    Beijing
    State
    CN-BJ
    Postal Code
    100176
    Country
    CN
    Correspondent
    Kun Yang

    Products

    Device Name Product Code
    Brush, Dermabrasion, Manual GED
    Static Electricity-Emitting Device, Cosmetic Use NZF
    Massager, Therapeutic, Electric ISA
    Powered Laser Surgical Instrument GEX
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Device, Pressure Applying KNM

    Proprietary Names

    Derma Stamp: Derma Stamp 0.25mm Dermabrasion Roller: Dermabrasion Stamp, Dermabrasion Roller derma roller, dermabrasion roller, derma stamp Derma Roller: Derma Roller 0.25mm, Microneedle Roller Koi Beauty Skin Therapy Wand; Koi Beauty Professional Skin Therapy Wand; Koi Beauty High Frequency Facial Wand plasma pen; plasma device DND:YAG Laser Therapy Systems Powered Muscle Stimulator CO2 Laser Therapy Systems LED light machine: LH40 PRO,LH50 PRO, LH60 PRO, LH70 PRO, LH80 PRO, Dr.Light, SK5026 LED light machine: SLM10,SLM20,SLM30,SLM33,SLM35,SLM40,SLM50,SLM60,SLM70,SLM80,SLM90,SLM100 Laser Machine: SH-LA-PNY20.SH-LA.PNY25,SH-LA.PNY25A,.SH-LA-PNY30. SH-LA-PNY50.SH-LA.VNY50,SH-LA.VCF100,SH-LA-DCF50. Hydra Dermabrasion Machine:SPA102,SPA200,SPA201,SPA202,SPA300,SPA301,SPA302,SPA400,SPA401,SPA402,SPA500,SPA501,SPA502 Laser Machine: CO2-L1,,CO2-L2,,CO2-1,CO2-2,CO2-3,CO2-4,LD-1,LD-2,LD-3,LD-4 Skin analyzer: SA-4S-15, SA-4S-15P, SA-3S-15, SA-3S-15P, SA-2S-12P, SA-2S-12, SA-5S-15, SA-5S-15P Water Mesotherapy Gun: HD400,HD500,HD600,HD700,HD800,HD900,HD1000, NV-H1,NV-H2,NV-H3,NV-H4,NV-H5,NV-H6,NV-H7 Diode Laser Hair Removal System:SH-LA-VD800,SH-LA-VD900,SH-DDL-100,SH-LA-PD100,SH-LA-VD910,SH-LA-VD920, SH-LA-VD950 Hydra Dermabrasion Machine:SPA10,SPA10E,SPA11,SPA12,SPA13,SPA14,SPA15,SPA16,SPA17,SPA18,SPA19,SPA20,SPA100,SPA101,SPA22 Electric Derma Pen: SH-DP-109, Dr.pen A1, Dr.pen A2, Dr.pen A3, Dr.pen A4, Dr.pen A5, Dr.pen A6,Dr.pen A7, Dr.pen A8 Water Mesotherapy Gun: SH-4,SH-5,SH-H1,SH-H2,SH-H3,SH-H4,SH-H5,SH-H6,SH-H7,SH-H8,SH-H9,SH-H10,HD100,HD200,HD300 RF microneedle machine:SH-RF-P10, SH-RF-P20, SH-RF-P30, SH-RF-P31, SH-RF-P32, SH-RF-P33, SH-RF-P34, SH-RF-P35, SH-RF-P36 Slimming Machine: SH-VC-1000,SH-DC-R51,SH-DC-100,SH-DC-400,SH-DC-R60,SH-DC-M30,SH-DC-300,SH-VC-G80,SH-DC-G80,SH-DC-R50 Skin analyzer: SA-DM1, SA-DM2, SA-DM3, SA-DM4, SA-DM5, ZA-H100, SA-H200, SA-H300, SA-H400, SA-H500, Hydra Dermabrasion Machine: SPA600,SPA601,SPA602,SPA700,SPA701,SPA702,SPA800,SPA801,SPA802,SPA900,SPA901,SPA902 Diode Laser Hair Removal System: ,SH-VD940,SH-VD950, SH-VD960,SH-VD980 Slimming Machine:SM-20, SM-30, SM-40, SM-50, SM-60, SM-70, SM-80, SM-90, SM-100, SM-200, SM-300, SM-400 Slimming Machine:SH-DC-500,SH-DC-M50,SH-VC-2000,SH-DC-200,SH-DC-R40,SH-DC-R30,SH-50,Lipo-3,SM-1,SM-2,RU+3,SM-3 Laser Machine: Bella-9,Bella-10,Bella-11,Bella-12,Bella-13,Bella-14,Bella-15,Bella-16,Bella-17 Derma Roller: LDR-540,EDR-75,EDR-180,EDR-240,HR64,DS-12,DS-20,DS-32,DS-34,DS-80,DS-140,DS-140A HIFEM Body Sculpting & Muscle Building Machine:HIFEM-3,HIFEM-4,HIFEM-5,HIFEM-6,HIFEM-7,HIFEM-8,HIFEM-9 Electric Derma Pen: SH-DP-100, SH-DP-101, SH-DP-102, SH-DP-103, SH-DP-104, SH-DP-105, SH-DP-106,SH-DP-107,SH-DP-108 Electric Derma Pen:Dr.pen A9, Dr.pen M1, Dr.pen M2, Dr.pen M3, Dr.pen M4, Dr.pen M5,Dr.pen M6, Dr.pen M7, Dr.pen M8 LED light machine: LED-V10,LED-V20,LED-V30,LED-V40,LED-V50,LED-V60,LED-V70,LED-V80,LED-V90,LED-V100, Diode Laser Hair Removal System: SH-VD860,SH-VD880,SH-VD900,SH-VD910,SH-VD920,SH-VD930 Electric Derma Pen: Dr.pen M9 Skin analyzer: SA-H600, HBA-GS5, HBA-GS5.5, HBA-GS6, HBA-GS6.5, HBA-GS7, HBA-GS7.5, HBA-GS8 Slimming Machine:CRF-8,CRF-9,CRF-10,CRF-11,GS-1,GS-2, SM-11, SM-12, SM-13, SM-14, SM-15, SM-16, SM-17, SM-18, SM-19 Laser Machine: SH-LA-VN100,.SH-CL-V100,SH-LA.PNF 10,Bella-1, Bella-2,Bella-3,Bella-4,Bella-5.Bella-6,Bella-7,Bella-8 Derma Roller : DR - 120, DR-192, DR-200, DR-400, DR-540, DR-600, DR-1080, DR-1200, LDR-75, LDR-180, LDR-192 Slimming Machine: SM-500, SM-600, SM-700, SM-800, SM-900 HIFEM Body Sculpting & Muscle Building Machine:,EMS-2,EMS-3,EMS-4,EMS-5,EMS-6,EMS-7,EMS-8,EMS-9,HIFEM-1,HIFEM-2, RF microneedle machine: W1, W2, W3, W4, W5, W6, W7, W8, W9 RF microneedle machine:SH-RF-P37, SH-RF-P38, SH-RF-P39, SH-RF-P40, SH-RF-P50, SH-RF-P60, SH-RF-P70, SH-RF-P80, SH-RF-P90 Water Mesotherapy Gun: NV-H8,NV-H9,NV-H10,HN100,HN200,HN300,,HN400,,HN500,,HN600,,HN700,,HN800,,HN900,,HN1000 Diode Laser Hair Removal System: SH-LA-VD960,SH-LA-VD980,SH-VD100,SH-VD200,SH-VD300,SH-VD400,SH-VD500,SH-VD600,SH-VD700 Diode Laser Hair Removal System: SH-VD800,SH-VD810,SH-VD820,SH-VD830,SH-VD840,SH-VD850, Slimming Machine:RU+5,SM-4,RU+6,SM-5,CRF-1,SM-6,CRF-2,SM-7,CRF-3,SM-8,CRF-4,SM-9,CRF-5,SM-10,CRF-6,CRF-7 HIFEM Body Sculpting & Muscle Building Machine:SM-1,SM-2,SM-3,SM-4,SM-5,SM-6,SM-7,SM-8,SM-9,SM-10,SM-12,SM-20,EMS-1

    Establishment Types

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