Sanhe Jumei Technology Co., Ltd.
Registered establishment in Sanhe, Hebei, China. 12 device types.
Sanhe Jumei Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Marker, Skin, Apparatus, Roller and 10 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | SANHE JUMEI TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031233197 |
| FEI number | 3031233197 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 三河聚美科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Sanhe |
|---|---|
| Province | Hebei |
| Address | 001, 1002, 1003, Building A1, Modern Service Industrial Park |
| Postal code | 065200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Roller | Class 1 | Roller Beauty System,Z710 | 2025 | 2 |
| Energy Based Device For Treatment Of Tattoos | Class 2 | Picosecond/ ND:YAG Laser Tattoo Removal & Pigmentation Removal System,, Z170Pro,Z150MAX ,Z170,Z170A,Z170B,Z180 | 2025 | 3 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | Class 2 | Shock Wave System,W970 | 2025 | 6 |
| Gas, Laser Generating | Class 1 | CO2 Fractional Laser System,Z121,Z131,Z131pro,Z190,Z190A;, Hydrogen Oxygen Small Bubble System,Z400 | 2025 | 17 |
| Laser Assisted Lipolysis | Class 2 | Lipo Laser System,W100C,W180,W180A | 2025 | 2 |
| Light Based Over-The-Counter Hair Removal | Class 2 | Diode Laser Hair Removal System,Z820,Z860,Z840,Z870,Z890;, Long Pluse ND-YAG Alexandrite Laser Hair Removal System,, Z110pro,Z110pro+,Z110Plus,Z110MAX,Z110MAX+ | 2025 | 69 |
| Marker, Skin | Class 1 | Skin/Body Analyzer Machine,W923;, SPA Facial Beauty System,Z400,Multi-functional OPT Beauty System, Z800,Z810,Z350 | 2025 | 55 |
| Powered Laser Surgical Instrument | Class 2 | Diode Laser Hair Removal System,Z890B,Z890C,Z890E, Q-Switched Nd:YAG Laser System,Z150,Z150pro, CO2 Laser Therapy Systems,Z131,Z131Pro,Z100,Z121,Z190,Z190A | 2024 | 92 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | Class 2 | CO2 Laser Therapy Systems,Z131,Z131Pro,Z100,Z121,Z190,Z190A | 2024 | 12 |
| Powered Microneedle Device | Class 2 | Powered microneedle device,Z709,Z720,W780 | 2025 | 10 |
| Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | Class 2 | Velashape Body Shaping System,Z700pro,Z700,Cavitation Slimming System,CV40C1,CV40K1,CV80Y1;, Multi-functional Cryolipolysis Slimming System,W680,W620,Z360;, HIEMT Body Sculpting & Muscle Building System,Z950,Z900,Z940,Z940Pro,W960A,W970 | 2025 | 6 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Powered Muscle Stimulator,Z950,Z900,Z940,Z940Pro,W960A,W970 | 2025 | 66 |
Clearances
No clearance names Sanhe Jumei Technology Co., Ltd. as applicant. 4 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. |
| K172908 | 2017-12-07 | GEX | Traditional | AMI Inc. |
| K162398 | 2017-07-06 | ONG | Traditional | Beijing Sincoheren Science and Technology Development Co. |
| K162659 | 2017-06-16 | GEX | Traditional | Shandong Huamei Technology Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Beijing Aeonmed Co., Ltd. | 7 |
| Hebei Zhemai Technology Co., Ltd. | 2 |
| Sanhe Meditech Co., Ltd. | 2 |
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.