Data / Medical devices / Taiwan / Bionime Corporation
Bionime Corporation: FDA-registered device maker in Taichung City, Taiwan, 12 510(k) clearances
Bionime Corporation is registered with the FDA (registration 3004183148) in Taichung City, Taiwan. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004183148
- Address
- NO. 100, Sec. 2, Daqing St., South Dist., Taichung City, Taiwan, 40242
- Owner or operator
- BIONIME CORPORATION (9059262)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 29, 2007
- Registered through
- 2026
- Brand names listed
- Diathrive Blood Glucose Test Strip, Diathrive+ Blood Glucose Monitoring System, Diathrive+ Bluetooth Blood Glucose Monitoring System, GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus, GE Blood Glucose Test Strip Max and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| November 4, 2024 | K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| September 26, 2022 | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | QRL | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 2, 2019 | K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| August 17, 2018 | K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| July 6, 2017 | K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| May 2, 2017 | K161790 | iGlucose Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 9, 2015 | K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Coporation | accessdata.fda.gov |
| June 3, 2015 | K143387 | GE333 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Coporation | accessdata.fda.gov |
| October 24, 2013 | K133003 | RIGHTEST CONTROL SOLUTION | JJX | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 18, 2010 | K092052 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| September 18, 2008 | K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| February 16, 2007 | K062567 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated November 4, 2024. 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.