Beijing SEA Heart International Science AND Technology Co., Ltd.
Registered establishment in Beijing, China. 7 device types.
Beijing SEA Heart International Science AND Technology Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Device, Pressure Applying, Brush, Dermabrasion, Manual and 5 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014388884 |
| FEI number | 3014388884 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 北京新海瑞腾国际科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Room 4009, Building 4, Zhongke Jingwei Industrial Park |
| Postal code | 100176 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | Class 1 | Derma Roller: Derma Roller 0.25mm, Microneedle Roller, Derma Stamp: Derma Stamp 0.25mm, Dermabrasion Roller: Dermabrasion Stamp, Dermabrasion Roller, derma roller, dermabrasion roller, derma stamp | 2019 | 21 |
| Device, Pressure Applying | Class 1 | 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, 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, Hydra Dermabrasion Machine: SPA600,SPA601,SPA602,SPA700,SPA701,SPA702,SPA800,SPA801,SPA802,SPA900,SPA901,SPA902, 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: 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 and 33 more | 2019 | 36 |
| Massager, Therapeutic, Electric | Class 1 | plasma pen; plasma device | 2026 | 437 |
| Powered Laser Surgical Instrument | Class 2 | CO2 Laser Therapy Systems, DND:YAG Laser Therapy Systems | 2025 | 92 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | Class 2 | CO2 Laser Therapy Systems | 2025 | 12 |
| Static Electricity-Emitting Device, Cosmetic Use | Class N | Koi Beauty Skin Therapy Wand; Koi Beauty Professional Skin Therapy Wand; Koi Beauty High Frequency Facial Wand | 2025 | 4 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Powered Muscle Stimulator | 2025 | 66 |
Clearances
No clearance names Beijing SEA Heart International Science AND Technology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242186 | 2024-09-17 | NGX | Traditional | Ofan Intelligent Technology (Guangzhou) Co., Ltd. |
| K193477 | 2020-06-24 | GEX | Traditional | Beijing KES Biology Technology Co., Ltd. |
| K162398 | 2017-07-06 | ONG | Traditional | Beijing Sincoheren Science and Technology Development Co. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Laser hair removal systems, Pico laser machines, Fractional CO2, HIFU, Hydra dermabrasion |
| Certifications | FDA, CE, ROHS, ISO9001, ISO13485 |
| Export markets | 80+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.