Bionime Corporation
Taichung City, TW
BIONIME CORPORATION appears in FDA device records in Taichung City, TW. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Bionime Corporation between 2005 and 2024. The busiest year on record is 2008, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2010 | 1 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | Substantially Equivalent | |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | Substantially Equivalent | |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | QRL | Substantially Equivalent | |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | NBW | Substantially Equivalent | |
| 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 | |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | NBW | Substantially Equivalent | |
| 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 | |
| K161790 | iGlucose Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | NBW | Substantially Equivalent | |
| K133003 | RIGHTEST CONTROL SOLUTION | JJX | Substantially Equivalent | |
| K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | NBW | Substantially Equivalent | |
| K120423 | BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 | NBW | Substantially Equivalent | |
| K110737 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 | NBW | Substantially Equivalent | |
| K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | JQP | Substantially Equivalent | |
| K092052 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 | NBW | Substantially Equivalent | |
| K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | NBW | Substantially Equivalent | |
| K081450 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 | NBW | Substantially Equivalent | |
| K072054 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 | NBW | Substantially Equivalent | |
| K062567 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K053635 | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K042678 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004183148 | 3004183148 | BIONIME CORPORATION | NO. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain