Visgeneer, Inc.

Medical device manufacturer in Hsinchu City, Taiw.

3510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K122181Ebchek Blood Glucose Monitoring SystemNBW · Traditional 08/15/2013SE
K091765Ebcarryon Blood Glucose Monitoring SystemNBW · Traditional 01/19/2010SE
K062555Ebsensor Blood Glucose Monitoring System, Model Eb-GNBW · Traditional 12/27/2006SE

Recalls

RecallProductInitiated
Z-2501-2025 Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user…Due to products distributed without premarket clearance or approvals. 10/04/2023Open, Classified
Z-2500-2025 Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user…Due to products distributed without premarket clearance or approvals. 10/04/2023Open, Classified