Data / Medical devices / China / Ningbo Xinwell Medical Technology Co., Ltd.
Ningbo Xinwell Medical Technology Co., Ltd.: FDA-registered device maker in Cixi Zhejiang, China, 2 510(k) clearances
Ningbo Xinwell Medical Technology Co., Ltd. is registered with the FDA (registration 3017178358) in Cixi Zhejiang, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017178358
- Address
- No.188 Binjiang Road,Cixi High-tech Industrial Development Zone, Cixi City, Zhejiang, 315301, P.R.China, Cixi Zhejiang, China, 315301
- Owner or operator
- Ningbo Xinwell Medical Technology Co., Ltd. (10075092)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 2008
- Registered through
- 2026
- Brand names listed
- All Ceramic Polishers, CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR), CATHETER,SUCTION, Circuit, breathing (w connector, adaptor, y piece), Disposable Dry Seal Chest Drainage System, Disposable Injection Needles, Disposable Water Seal Chest Drainage System, Disposable biopsy forceps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Contract manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | 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 |
| Hemostatic Metal Clip For The Gi Tract | PKL | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Contract 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 7, 2024 | K232969 | Disposable Hemostatic Clips | PKL | Substantially Equivalent | Ningbo Xinwell Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 12, 2024 | K232200 | Disposable Injection Needles | FBK | Substantially Equivalent | Ningbo Xinwell Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Point, Abrasive
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Mask, Gas, Anesthetic
Updated June 7, 2024. 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.