This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Hong Kong — 6 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K170118 | Scanostics UTI Check Application Test System | 2017-09-21 |
| US | K161527 | Teco Creatinine Enzymatic Reagent Kit | 2017-07-21 |
| US | K170200 | Carbon Dioxide Reagent Set | 2017-06-01 |
| CA | 72391 | URINE REAGENT STRIPS FOR URINALYSIS | Class III |