Hebei Zhemai Technology Co., Ltd.
Manufacturer and brand owner in Sanhe, Hebei, China. 2 device types, 2 products catalogued, 3 clearances.
Hebei Zhemai Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
2device types registered with the FDA
2products catalogued under its own name
3510(k) clearances
Registration
| Registered name | HEBEI ZHEMAI TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3032147807 |
| FEI number | 3032147807 |
| DUNS | 715544310 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 河北喆迈科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Sanhe |
|---|---|
| Province | Hebei |
| Address | On the second floor of Building 14 #1-101,Phase l, Zhongnan High tech,Yanjiao Science and Technology |
| Postal code | 065201 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | Class 2 | Q-Switched Nd:Yag laser(FQ-L08), Tri-Pulse, Diode laser therapy device(FD-L01) | 2024 | 92 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | Intense pulsed light therapy device(FI-L06), Bubbl | 2024 | 31 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232708 | 2023-12-01 | ONF | Traditional | This company |
| K232716 | 2023-11-30 | GEX | Traditional | This company |
| K232709 | 2023-11-30 | GEX | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Sanhe Jumei Technology Co., Ltd. | 12 |
| Beijing Aeonmed Co., Ltd. | 7 |
| 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.