Beijing Sanhe Tech Co., Ltd.

Registered establishment in Beijing, China. 2 device types.

Registry build 21.09.26

Beijing Sanhe Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Stimulator, Muscle, Powered, For Muscle Conditioning. Its earliest product listing with the FDA dates from 2022.

Registration

FDA registration record for Beijing Sanhe Tech Co., Ltd.
Registered name BEIJING SANHE TECH CO., LTD.
Status Registered
Registration expires 2026
Registration number 3017173524
FEI number 3017173524
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Beijing Sanhe Tech Co., Ltd.
Chinese legal name 北京三和鼎业科技有限公司
Source Qichacha company register

Location

Address of Beijing Sanhe Tech Co., Ltd.
City Beijing
Province Beijing
Address Room 7-204, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China
Postal code 101300
Country China

What It Makes

Device types Beijing Sanhe Tech Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Powered Laser Surgical Instrument Class 2 Q-Switched Nd:YAG Laser SHE-LSP101-1, CO2 Laser Therapy Systems, Powered Laser Surgical Instrument, Cryoiet Plus(SHE-ACP001-1) 2022 92
Stimulator, Muscle, Powered, For Muscle Conditioning Class 2 HI-EMT Magshape 2025 66

Clearances

No clearance names Beijing Sanhe Tech Co., Ltd. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Beijing Sanhe Tech Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K250936 2025-06-12 GEX Traditional Beijing Sano Laser S&T Development Co., Ltd.
K242941 2025-01-27 GEX Traditional Beijing Sano Laser S&T Development Co., Ltd.
K233416 2024-02-06 GEX Traditional Beijing Sano Laser S&T Development Co., Ltd.
K230024 2023-09-06 NGX Traditional Beijing Sano Laser S&T Development Co., Ltd.
K191970 2020-04-06 GEX Traditional Beijing Sano Laser S&T Development Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Beijing Sanhe Tech Co., Ltd.
Founded 2005
Employees 200-300
Factory area 100000 m²
Main products laser hair removal, aesthetic lasers, cryolipolysis machines, RF microneedle systems, tattoo removal lasers
Certifications FDA, CE, ISO certifications
Export markets Global markets, 100+ countries
OEM and ODM Offered

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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.

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