Visgeneer, Inc.
Hsinchu City, TW
VISGENEER, INC. appears in FDA device records in Hsinchu City, TW. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 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 3 510(k) clearances for Visgeneer, Inc. between 2006 and 2013. The busiest year on record is 2006, with 1. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122181 | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K091765 | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K062555 | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005644014 | 3005644014 | VISGENEER, INC. | NO. 335, SEC. 6, HSINCHU CITY Hsinchu(City) 30094 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2501-2025 | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) | Due to products distributed without premarket clearance or approvals. | Class II | Open, Classified | |
| Z-2500-2025 | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) | Due to products distributed without premarket clearance or approvals. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain