Data / Medical devices / China / Changsha Sinocare Inc.
Changsha Sinocare Inc.: FDA-registered device maker in Changsha Hunan, China, 2 510(k) clearances
Changsha Sinocare Inc. is registered with the FDA (registration 3016863723) in Changsha Hunan, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016863723
- Address
- No.265 Guyuan Road, Hi-Tech Zone, Changsha Hunan, China, 410205
- Owner or operator
- Changsha Sinocare Inc. (10064101)
- Roles
- Manufacturer
- First device listed
- December 11, 2022
- Registered through
- 2026
- Brand names listed
- Gold AQ Blood Glucose Monitoring System, TRUENESS, TRUENESS AIR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| December 1, 2023 | K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | NBW | Substantially Equivalent | Sinocare, Inc. | accessdata.fda.gov |
| October 5, 2017 | K170264 | Gold AQ Blood Glucose Monitoring System | NBW | Substantially Equivalent | Changsha Sinocare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated December 1, 2023. 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.