Data / Medical devices / China / Longfian Scitech Co., Ltd.
Longfian Scitech Co., Ltd.: FDA-registered device maker in Baoding Hebei, China, 3 510(k) clearances
Longfian Scitech Co., Ltd. is registered with the FDA (registration 3006991053) in Baoding Hebei, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006991053
- Address
- Building B5, Kechuang Branch, National University Science Park, No. 666 Lixing Street, Baoding Hebei, China, 071051
- Owner or operator
- LONGFIAN SCITECH CO., LTD. (10047648)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 16, 2014
- Registered through
- 2026
- Brand names listed
- JAY-1000P, JAY-5, JAY-5AW, POC5000, SOC5100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| September 29, 2025 | K243833 | Portable oxygen concentrator (JAY-1000P) | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K213210 | Oxygen Concentrator, Model JAY-5AW | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| September 5, 2014 | K131968 | LONGFIAN OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Updated September 29, 2025. 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.