Beijing Hanbaihan Medical Devices Co., Ltd.
Registered establishment in Beijing, China. 4 device types.
Beijing Hanbaihan Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Laser, Comb, Hair, System, Blood Collection, Vacuum-Assisted, Manual and 2 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015086789 |
| FEI number | 3015086789 |
| Establishment type | Contract manufacturer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 北京汉佰瀚医疗器械有限公司 |
|---|---|
| Unified social credit code | 91110112587676412K |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Floor 1-4, 101, Building 18, Campus 6, 8th Hengye Street,Tongzhou |
| Postal code | 101104 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | Medical Centrifuge | 2022 | 37 |
| Laser, Comb, Hair | Class 2 | Hair Growth Device | 2023 | 30 |
| Platelet And Plasma Separator For Bone Graft Handling | Class 2 | BTR Prp,hbh PRP, Margenix PRP | 2018 | 2 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | System, Blood Collection, Vacuum-Assisted, Manual – Blood Collection; System, Blood Collection, Vacuum-Assisted, Manual | 2022 | 31 |
Clearances
No clearance names Beijing Hanbaihan Medical Devices Co., Ltd. as applicant. One is 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.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210169 | 2021-04-16 | OAP | Traditional | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 20+ experts |
|---|---|
| Factory area | 2,000+ m² |
| Main products | Blood collection tubes, PRP tubes, PRP kits, Virus sampling tubes, PRP centrifuges |
| Certifications | FDA, CE MDR, ISO13485, GMP, FSC |
| Export markets | 200+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
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.