Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd.
Registered establishment in Jintan, Jiangsu, China. 10 device types, 1 clearance.
Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Spoon, Ear, Anesthesia Kit and 8 other device types. Its earliest product listing with the FDA dates from 2014.
10device types registered with the FDA
1510(k) clearance
Registration
| Registered name | Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011252788 |
| FEI number | 3011252788 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Jintan |
|---|---|
| Province | Jiangsu |
| Address | No. 8, Jianerkang Road |
| Postal code | 213200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Spoon, EAR | 2014 | 84 |
| Anesthesia Kit | Class 2 | Anesthesia kit | 2019 | 3 |
| Catheter, Retention Type, Balloon | Class 2 | Catheter, Retention Type, Balloon | 2018 | 17 |
| Container, Specimen, Non-Sterile | Class 1 | Container, Specimen, NON- Sterile | 2024 | 115 |
| Spoon, Ear | Class 1 | Spoon, EAR | 2015 | 6 |
| Stylet, Tracheal Tube | Class 1 | Stylet, Tracheal Tube | 2019 | 34 |
| Tray, Surgical, Instrument | Class 1 | needle counter | 2015 | 105 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Tube, Aspirating, Flexible, Connecting | 2018 | 51 |
| Tubing, Noninvasive | Class 2 | Connecting tube | 2018 | 33 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class 1 | Tubing/tubing with filter, insufflation, laparoscopic | 2023 | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K172807 | 2018-06-04 | EZL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Laryngeal mask airway kits, Nasopharyngeal airway kits, Polymer medical devices |
| Certifications | FDA |
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.