Data / Medical devices / Taiwan / Visgeneer, Inc.
Visgeneer, Inc.: FDA-registered device maker in HSINCHU CITY Hsinchu(City), Taiwan, 4 510(k) clearances
Visgeneer, Inc. is registered with the FDA (registration 3005644014) in HSINCHU CITY Hsinchu(City), Taiwan. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 7, 2022. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005644014
- Address
- NO. 335, SEC. 6 Zhonghua ROAD, HSINCHU CITY Hsinchu(City), Taiwan, 30094
- Owner or operator
- VISGENEER, INC. (9084502)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 2, 2007
- Registered through
- 2027
- Brand names listed
- eB-Tchol, eBcarryon, eBchek, eBketolife blood ketone meter, eBketolife blood ketone monitoring system, eBketolife blood ketone test strip, eBketone blood ketone meter, eBketone blood ketone monitoring system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 7, 2022 | K222034 | RightLance Blood Lancing System | QRL | Substantially Equivalent | Beijing Ruicheng Medical Supplies Co., Ltd. | accessdata.fda.gov |
| August 15, 2013 | K122181 | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Visgeneer, Inc. | accessdata.fda.gov |
| January 19, 2010 | K091765 | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Visgeneer, Inc. | accessdata.fda.gov |
| December 27, 2006 | K062555 | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G | NBW | Substantially Equivalent | Visgeneer, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 4, 2023 | 97328 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
Updated September 2, 2025. 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.