Data / Medical devices / China / Beijing Hanbaihan Medical Devices Co., Ltd.
Beijing Hanbaihan Medical Devices Co., Ltd.: FDA-registered device maker in Beijing City, China, 1 510(k) clearance
Beijing Hanbaihan Medical Devices Co., Ltd. is registered with the FDA (registration 3015086789) in Beijing City, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015086789
- Address
- Floor 1-4, 101, Building 18, Campus 6, 8th Hengye Street,Tongzhou, Beijing City, China, 101104
- Owner or operator
- Beijing Hanbaihan Medical Devices Co., Ltd. (10059234)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- December 13, 2018
- Registered through
- 2026
- Brand names listed
- BTR PRP,HBH PRP, Hair Growth Device, Margenix PRP, Medical Centrifuge, System, Blood Collection, Vacuum-Assisted, Manual - Blood Collection; System, Blood Collection, Vacuum-Assisted, Manual
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | 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 |
|---|---|---|---|---|---|---|
| April 16, 2021 | K210169 | Hair Growth Device | OAP | Substantially Equivalent | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Laser, Comb, Hair
Updated April 16, 2021. 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.