Ningbo Huakun Medical Equipment Co., Ltd.
Registered establishment in Cixi, Zhejiang, China. 19 device types, 1 clearance.
Ningbo Huakun Medical Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Bag, Reservoir and 17 other device types. Its earliest product listing with the FDA dates from 2012.
19device types registered with the FDA
1510(k) clearance
Registration
| Registered name | NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009747810 |
| FEI number | 3009747810 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 宁波华坤医疗器械有限公司 |
|---|---|
| Unified social credit code | 913302827532554461 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Cixi |
|---|---|
| Province | Zhejiang |
| Address | NO.208 Binjiang Road, Cixi High-tech Industrial Development Zone |
| Postal code | 315301 |
| Country | China |
What It Makes
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221472 | 2023-02-08 | CAH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Anesthesia breathing circuits, Endotracheal tubes, Humidifiers, Bacterial filters, Anesthesia laryngoscopes |
| Certifications | GMP |
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.