Bonree Medical Co., Ltd.
Registered establishment in Zhongshan, Guangdong, China. 11 device types, 1 clearance.
Bonree Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Stylet, Tracheal Tube and 9 other device types. Its earliest product listing with the FDA dates from 2016.
11device types registered with the FDA
1510(k) clearance
Registration
| Registered name | BONREE MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013055504 |
| FEI number | 3013055504 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 中山博睿医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | 1st floor of Building No.2, Building No.4 |
| Postal code | 528451 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | Nasopharyngeal Airway | 2016 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal Airway, Laryngeal Mask Device | 2016 | 84 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | Apparatus Suction, Suction Catheter | 2016 | 30 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Oxygen | 2016 | 97 |
| Catheter And Tip, Suction | Class 2 | Yankauer Suction Set, Yankauer Suction Tip W/Tubing, Pressure Tubing Suction Catheter, Yankauer Suction Hande, Yankauer Suction Tube | 2016 | 70 |
| Mask, Oxygen | Class 1 | Oxygen Mask | 2016 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-Rebreathing Oxygen Mask | 2016 | 72 |
| Stylet, Tracheal Tube | Class 1 | Tracheal Tube Stylet, Bougie | 2016 | 34 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Sterile Catheter | 2017 | 23 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction Tubing, Aspiration Tubing | 2025 | 51 |
| Tubing, Pressure And Accessories | Class 1 | Pressure Tubing, Oxygen Tubing | 2016 | 45 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212430 | 2022-04-29 | EZD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Employees | 201-500 |
| Main products | Medical catheters, Respiratory devices, Anesthesia catheters, Urology devices, Nursing supplies |
| Certifications | CE, ISO13485, FDA |
| 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.