Shenzhen BI-Rich Medical Devices Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 9 device types, 1 clearance.
Shenzhen BI-Rich Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Unit, Filter, Membrane and 7 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011716786 |
| FEI number | 3011716786 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市百瑞琪医疗器械有限公司 |
|---|---|
| Unified social credit code | 9144030035786512XY |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No. 10, Xinqiao GangZai Road |
| Postal code | 518125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Compressor, Air, Portable | Class 2 | Compressor Nebulizer | 2015 | 23 |
| Mask, Oxygen | Class 1 | 2025 | 126 | |
| Mask, Oxygen, Non-Rebreathing | Class 1 | 2025 | 72 | |
| Meter, Peak Flow, Spirometry | Class 2 | Peak Flow Meter | 2026 | 6 |
| Nebulizer (Direct Patient Interface) | Class 2 | Medline Hudson RCI MICRO-MIST Nebulizer, Nebulizer | 2016 | 42 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | 2021 | 14 | |
| Tube, Aspirating, Flexible, Connecting | Class 2 | 2021 | 51 | |
| Unit, Filter, Membrane | Class 1 | 2021 | 17 | |
| Vacuum Powered Body Fluid Collection Kit | Class 2 | 2021 | 1 |
Clearances
1 clearance names Shenzhen BI-Rich Medical Devices Co., Ltd. as applicant. 1 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 |
|---|---|---|---|---|
| K252802 | 2026-05-29 | BZH | Traditional | This company |
| K091272 | 2009-11-10 | CAF | Traditional | Besmed Health Business Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | 200+ |
| Factory area | 10000 m2+ |
| Main products | Compressor nebulizer, Sleep apnea machine, Phlegm suction machine, Oxygen concentrator, Infrared thermometer |
| Certifications | ISO13485, CE, FDA, GMP, National High-tech Enterprise |
| Export markets | 60+ countries including US, Russia, Germany, Italy, Brazil, Middle East, Southeast Asia |
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.