This company has registrations in United States, Canada — 2 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 | K092349 | CLEARVIEW EXACT II INFLUENZA A & B TEST | 2010-05-10 |
| US | K071265 | SMARTCHECK INR SYSTEM | 2007-11-30 |
| US | K071587 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY | 2007-07-30 |
| CA | 28000 | THIN LANCETS | Class II |
| CA | 30538 | BLOOD GLUCOSE TEST STRIPS G | Class III |