Changsha Sinocare Inc.
Registered establishment in Changsha, Hunan, China. 2 device types, 1 clearance.
Changsha Sinocare Inc. is a manufacturer holding a current FDA establishment registration. The registration covers System, Test, Blood Glucose, Over The Counter, Single (Specified) Analyte Controls (Assayed And Unassayed). Its earliest product listing with the FDA dates from 2022.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3016863723 |
| FEI number | 3016863723 |
| Establishment type | Manufacturer |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | No.265 Guyuan Road, Hi-Tech Zone |
| Postal code | 410205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | Trueness | 2024 | 12 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | Gold AQ Blood Glucose Monitoring System, Trueness, Trueness AIR | 2022 | 20 |
Clearances
1 clearance names Changsha Sinocare Inc. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K170264 | 2017-10-05 | NBW | Traditional | This company |
| K231476 | 2023-12-01 | NBW | Traditional | Sinocare, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | blood glucose meters, blood pressure monitors, uric acid meters, CGM systems, glycated hemoglobin analyzers |
| Export markets | 187 countries and regions globally |
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.