This company has registrations in United States, Canada, Taiwan, Singapore, South Korea — 5 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 | K923768 | PULSE CRP TEST | 1992-12-01 |
| US | K923767 | PULSE IM RED CELL TEST | 1992-10-16 |
| US | K923771 | PULSE RF TEST | 1992-10-05 |
| CA | 4857 | PREGNANCY MONOCLONAL (LATEX) TEST | Class II |
| CA | 4862 | PREGNANCY SELFTEST TEST | Class II |
| CA | 4863 | LUTEINIZING HORMONE (LH) DIPSTICK TEST | Class II |