Ninghai Guangjie Electronic Commerce Co., Ltd.
Registered establishment in Ningbo, Zhejiang, China. 3 device types.
Ninghai Guangjie Electronic Commerce Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Monitor, Ultrasonic, Fetal, Ventilator, Non-Continuous (Respirator) and 1 other device type. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | NINGHAI GUANGJIE ELECTRONIC COMMERCE CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043709870 |
| FEI number | 3043709870 |
| Establishment type | Manufacturer |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | Zhenxing North Road, Xidian Town No. 90-3, Senhai Mansion Ninghai County |
| Postal code | 315613 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | CPAP Machine for Sleep Apnea | 2026 | 12 |
| Monitor, Ultrasonic, Fetal | Class 2 | Fetal Doppler | 2026 | 13 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | CPAP Machine for Sleep Apnea | 2026 | 18 |
Clearances
No clearance names Ninghai Guangjie Electronic Commerce Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K010263 | 2001-03-29 | BZD | Traditional | Respironics Inc. |
| K920056 | 1992-12-11 | KNG | Traditional | Medical Accessories, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Terminals, Various connectors |
|---|
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.