Data / Medical devices / China / Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd
Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd: FDA-registered device maker in Jintan Jiangsu, China, 1 510(k) clearance
Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd is registered with the FDA (registration 3011252788) in Jintan Jiangsu, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 4, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011252788
- Address
- No. 8, Jianerkang Road IndustrialConcentration Area,Zhixi Town, Jintan Jiangsu, China, 213200
- Owner or operator
- Changzhou Rongxin Medicine Minimal Invasion Tech. Co., Ltd. (10047661)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 16, 2014
- Registered through
- 2027
- Brand names listed
- Anesthesia kit, CATHETER, RETENTION TYPE, BALLOON, CONTAINER, SPECIMEN, NON- STERILE, Connecting tube, SPOON, EAR, STYLET, TRACHEAL TUBE, TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Tubing/tubing with filter, insufflation, laparoscopic and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Anesthesia Kit | OFQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Spoon, Ear | JZE | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2018 | K172807 | Silicone Foley Catheter for single use | EZL | Substantially Equivalent | Changzhou Rongxin Medicine Minimal Invasion Technology | accessdata.fda.gov |
Compare with other makers
- All makers of Anesthesia Kit
- All makers of Tube, Aspirating, Flexible, Connecting
- All makers of Spoon, Ear
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Tray, Surgical, Instrument
- All makers of Container, Specimen, Non-Sterile
Updated June 4, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.