Data / Medical devices / China / Hebei Newangie Technology Co., Ltd
Hebei Newangie Technology Co., Ltd: FDA-registered device maker in Shijiazhuang Hebei, China, 2 510(k) clearances
Hebei Newangie Technology Co., Ltd is registered with the FDA (registration 3030543531) in Shijiazhuang Hebei, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030543531
- Address
- Room 402, Building A-5, Guoxietang Industrial Park, No. 509 TaihangSouth Street, Hi-Tech Zone, Shijiazhuang Hebei, China, 050035
- Owner or operator
- Hebei Newangie Technology Co., Ltd (10089994)
- Roles
- Manufacturer
- First device listed
- January 30, 2024
- Registered through
- 2026
- Brand names listed
- Diode laser device (BM091), Picosecond laser device (BMPS4), Roller massage lymphatic drainage device-M15, Roller massage lymphatic drainage device-M9+10S, Roller massage lymphatic drainage device-M9+11S, Roller massage lymphatic drainage device-M9+12S, Roller massage lymphatic drainage device-M9+13S, Roller massage lymphatic drainage device-M9+14S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2025 | K252447 | Picosecond laser device (BMPS4) | GEX | Substantially Equivalent | Hebei Newangie Technology Co., Ltd. | accessdata.fda.gov |
| August 8, 2025 | K251801 | Diode laser device (BM091) | GEX | Substantially Equivalent | Hebei Newangie Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.