Data / Medical devices / China / Jiangsu Changmei Medtech Co.,ltd
Jiangsu Changmei Medtech Co.,ltd: FDA-registered device maker in Changzhou Jiangsu, China, 1 510(k) clearance
Jiangsu Changmei Medtech Co.,ltd is registered with the FDA (registration 3016789487) in Changzhou Jiangsu, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016789487
- Address
- No.27, Xinke West Road, Luoyang Town, Wujin District, Changzhou Jiangsu, China, 213104
- Owner or operator
- Jiangsu Changmei Medtech Co.,Ltd (10065161)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- August 17, 2023
- Registered through
- 2026
- Brand names listed
- Balloon Inflator, Dilation Balloon Catheter, Disposable Endoscopic Hose-type Biopsy Forceps, Kyphoplasty Balloon Catheter, Kyphoplasty Tool Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Esophageal | KNQ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dispenser, Cement | KIH | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 16, 2023 | K223709 | Kyphoplasty Balloon Catheter | HRX | Substantially Equivalent | Jiangsu Changmei Medtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tamp
- All makers of Dispenser, Cement
- All makers of Arthroscope
- All makers of Injector, Vertebroplasty (Does Not Contain Cement)
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Dilator, Esophageal
Updated August 16, 2023. 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.