Data / Medical devices / China / Hebei Xinle Sci&tech Co.,ltd
Hebei Xinle Sci&tech Co.,ltd: FDA-registered device maker in Shijiazhuang City Hebei, China, 1 510(k) clearance
Hebei Xinle Sci&tech Co.,ltd is registered with the FDA (registration 3014498762) in Shijiazhuang City Hebei, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 19, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498762
- Address
- No. 2, Xingye Street, Xinle City, Shijiazhuang City Hebei, China, 050700
- Owner or operator
- Hebei Xinle Sci&Tech Co.,Ltd (10057534)
- Roles
- Manufacturer
- First device listed
- July 17, 2023
- Registered through
- 2027
- Brand names listed
- Lancet, VivaGuard SAFETY LANCETS, XL-B 21G, XL-B 28G, XL-B 30G, XL-C 21G, XL-C 28G, XL-C 30G, XL-E 21G, XL-E 28G, XL-E 30G
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 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 |
|---|---|---|---|---|---|---|
| September 19, 2022 | K221839 | Lancet | FMK | Substantially Equivalent | Hebei Xinle Sci&Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2022. 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.