FDA Registration
Active
🇨🇳 China
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
Reg #: 3014388884
·
FEI: 3014388884
·
Expires 2025
Products
1
Proprietary Names
39
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD.
- Registration Number
- 3014388884
- FEI Number
- 3014388884
- Status
- Active
- Expiry Year
- 2025
- 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
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2019-12-12 |
Proprietary Names
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
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
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
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: SPA600,SPA601,SPA602,SPA700,SPA701,SPA702,SPA800,SPA801,SPA802,SPA900,SPA901,SPA902
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
RF microneedle machine: W1, W2, W3, W4, W5, W6, W7, W8, W9
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
LED light machine: LED-V10,LED-V20,LED-V30,LED-V40,LED-V50,LED-V60,LED-V70,LED-V80,LED-V90,LED-V100,
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
Laser Machine: CO2-L1,,CO2-L2,,CO2-1,CO2-2,CO2-3,CO2-4,LD-1,LD-2,LD-3,LD-4
Diode Laser Hair Removal System: SH-VD860,SH-VD880,SH-VD900,SH-VD910,SH-VD920,SH-VD930
LED light machine: LH40 PRO,LH50 PRO, LH60 PRO, LH70 PRO, LH80 PRO, Dr.Light, SK5026
Skin analyzer: SA-H600, HBA-GS5, HBA-GS5.5, HBA-GS6, HBA-GS6.5, HBA-GS7, HBA-GS7.5, HBA-GS8
HIFEM Body Sculpting & Muscle Building Machine:HIFEM-3,HIFEM-4,HIFEM-5,HIFEM-6,HIFEM-7,HIFEM-8,HIFEM-9
Water Mesotherapy Gun: HD400,HD500,HD600,HD700,HD800,HD900,HD1000, NV-H1,NV-H2,NV-H3,NV-H4,NV-H5,NV-H6,NV-H7
Hydra Dermabrasion Machine:SPA102,SPA200,SPA201,SPA202,SPA300,SPA301,SPA302,SPA400,SPA401,SPA402,SPA500,SPA501,SPA502
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
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
Diode Laser Hair Removal System: SH-VD800,SH-VD810,SH-VD820,SH-VD830,SH-VD840,SH-VD850,
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
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
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
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
Slimming Machine: SM-500, SM-600, SM-700, SM-800, SM-900
Skin analyzer: SA-DM1, SA-DM2, SA-DM3, SA-DM4, SA-DM5, ZA-H100, SA-H200, SA-H300, SA-H400, SA-H500,
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
Water Mesotherapy Gun: NV-H8,NV-H9,NV-H10,HN100,HN200,HN300,,HN400,,HN500,,HN600,,HN700,,HN800,,HN900,,HN1000
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.
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
LED light machine: SLM10,SLM20,SLM30,SLM33,SLM35,SLM40,SLM50,SLM60,SLM70,SLM80,SLM90,SLM100
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
Laser Machine: Bella-9,Bella-10,Bella-11,Bella-12,Bella-13,Bella-14,Bella-15,Bella-16,Bella-17
Derma Roller : DR - 120, DR-192, DR-200, DR-400, DR-540, DR-600, DR-1080, DR-1200, LDR-75, LDR-180, LDR-192
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,
Electric Derma Pen: Dr.pen M9
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
Diode Laser Hair Removal System: ,SH-VD940,SH-VD950, SH-VD960,SH-VD980
Hydra Dermabrasion Machine:SPA10,SPA10E,SPA11,SPA12,SPA13,SPA14,SPA15,SPA16,SPA17,SPA18,SPA19,SPA20,SPA100,SPA101
Establishment Types
Export Device to the United States But Perform No Other Operation on Device