Resvent Medical Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 6 device types, 1 clearance.
Resvent Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Support, Breathing Tube, Medical Device Data System and 4 other device types. Its earliest product listing with the FDA dates from 2021.
6device types registered with the FDA
1510(k) clearance
Registration
| Registered name | RESVENT MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3019793765 |
| FEI number | 3019793765 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳融昕医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440300358733444J |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | BC601, Gaoxinqi Factory, District 67 Xingdong Community,Xinan Street, Baoan District |
| Postal code | 518100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Disposable Anesthesia Breathing Circuit | 2023 | 55 |
| Continuous Ventilator, Minimal Ventilatory Support | Class N | iBreeze PAP (iBreeze 20A; iBreeze 25ST; iBreeze 25STA) | 2021 | 3 |
| Medical Device Data System | Class 1 | iMatrix Sleeping Management Software, ResAssist | 2022 | 11 |
| Non-Continuous Ventilator For Emergency Use | Class N | IBreeze 30STA Device (IBreeze 30STA) | 2021 | 1 |
| Support, Breathing Tube | Class 1 | Tube | 2022 | 14 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | RXiBreeze PAP System, RXiBreeze 20C | 2026 | 18 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253044 | 2026-07-23 | BZD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Sleep apnea treatment devices, COPD treatment equipment, Mechanical ventilation systems, Sleep diagnostic equipment, Cloud information systems |
| Certifications | CE, FDA EUA, NMPA, Guangdong Well-known Brand |
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.