Data / Medical devices / China / Changzhou Newmed Micro-Medtech Co., Ltd.
Changzhou Newmed Micro-Medtech Co., Ltd.: FDA-registered device maker in Changzhou City Jiangsu, China, 1 510(k) clearance
Changzhou Newmed Micro-Medtech Co., Ltd. is registered with the FDA (registration 3043141270) in Changzhou City Jiangsu, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043141270
- Address
- NO.99 of Longxi Avenue,Zhulin Town,Jintan District,Changzhou City,Jiangsu Province,China, Changzhou City Jiangsu, China, 213241
- Owner or operator
- Changzhou NewMed Micro-Medtech Co., Ltd. (10094810)
- Roles
- Manufacturer
- First device listed
- December 24, 2025
- Registered through
- 2026
- Brand names listed
- Disposable Biopsy Forceps, Disposable Cold Snare Device, Disposable Endoscopic Injection Needles, Disposable Grasping Forceps, Disposable Spray Catheter, Disposable endoscope retrieval net
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer | accessdata.fda.gov |
| Snare, Non-Electrical | FGX | 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 |
|---|---|---|---|---|---|---|
| December 2, 2025 | K252021 | Disposable Endoscopic Injection Needles | FBK | Substantially Equivalent | Changzhou New Med Micro-Medtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Accessories, Catheter
- All makers of Snare, Non-Electrical
Updated December 2, 2025. 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.