Ningbo Xinwell Medical Technology Co., Ltd.
Manufacturer and brand owner in Cixi, Zhejiang, China. 12 device types, 5 products catalogued, 2 clearances.
Ningbo Xinwell Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Point, Abrasive, Blood Pressure Cuff and 10 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
12device types registered with the FDA
5products catalogued under its own name
2510(k) clearances
Registration
| Registered name | NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017178358 |
| FEI number | 3017178358 |
| DUNS | 544587864 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 宁波新跃医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91330200MA293LCD5X |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Cixi |
|---|---|
| Province | Zhejiang |
| Address | No.188 Binjiang Road,Cixi High-tech Industrial Development Zone, Cixi City, Zhejiang, 315301, P.R.China |
| Postal code | 315301 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | All Ceramic Polishers, FlexiPoints, Mass Spectrometry Monitoring Line Cononectors | 2025 | 29 |
| Blood Pressure Cuff | Class 2 | K120364, blood pressure cuff | 2020 | 50 |
| Bottle, Collection, Vacuum | Class 2 | Disposable Water Seal Chest Drainage System, Disposable Dry Seal Chest Drainage System | 2021 | 88 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | Patient monitoring Cables for ECG, EKG, SpO2 and Blood Pressure Monitors, Cable, Transducer AND Electrode, Patient, (Including Connector) | 2020 | 22 |
| Catheters, Suction, Tracheobronchial | Class 1 | Catheter,suction | 2022 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Circuit, breathing (w connector, adaptor, y piece) | 2020 | 55 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Disposable Injection Needles | 2024 | 23 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable biopsy forceps | 2021 | 44 |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | Hemostatic Metal Clip For The Gi Tract-Disposable Hemostatic Clips | 2024 | 17 |
| Laryngoscope, Rigid | Class 1 | Video laryngoscope | 2021 | 44 |
| Mask, Gas, Anesthetic | Class 1 | Mask, GAS, Anesthetic | 2021 | 71 |
| Point, Abrasive | Class 1 | All Ceramic Polishers, FlexiPoints, Mass Spectrometry Monitoring Line Cononectors | 2008 | 9 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Disposable Endoscopic Biopsy Forceps | FCL | 384 |
| Disposable Hemostatic Clips | PKL | 160 |
| Disposable Injection Needles | FBK | 150 |
| Closed Suction Catheters | BSY | 38 |
| Disposable Anesthetic Masks | BSJ | 14 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232969 | 2024-06-07 | PKL | Traditional | This company |
| K232200 | 2024-04-12 | FBK | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Chest tube drainage systems, Core needle biopsy devices, Anesthesia circuits |
|---|---|
| Export markets | Global – international exhibitions CMEF, MEDICA, Japan Health, FIME, Hospitalar |
Nearby Manufacturers
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.