Data / Medical devices / China / Ninghai Guangjie Electronic Commerce Co., Ltd
Ninghai Guangjie Electronic Commerce Co., Ltd: FDA-registered device maker in Ningbo Zhejiang, China, 2 510(k) clearances
Ninghai Guangjie Electronic Commerce Co., Ltd is registered with the FDA (registration 3043709870) in Ningbo Zhejiang, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 29, 2001. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3043709870
- Address
- Zhenxing North Road, Xidian Town No. 90-3, Senhai Mansion Ninghai County, Ningbo Zhejiang, China, 315613
- Owner or operator
- Ninghai Guangjie Electronic Commerce Co., Ltd (10095082)
- Roles
- Manufacturer
- First device listed
- January 21, 2026
- Registered through
- 2026
- Brand names listed
- CPAP Machine for Sleep Apnea, Fetal Doppler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Ultrasonic, Fetal | KNG | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | 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 |
|---|---|---|---|---|---|---|
| March 29, 2001 | K010263 | REMSTAR PLUS CPAP SYSTEM | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 11, 1992 | K920056 | POCKET SIZE FETAL HEART DETECTOR | KNG | Substantially Equivalent | Medical Accessories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Monitor, Ultrasonic, Fetal
Updated March 29, 2001. 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.