This company has registrations in United States, Brazil, Australia, Israel, Russia — 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 | K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | 2025-03-18 |
| US | K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | 2024-01-10 |
| US | K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | 2024-01-09 |
| BR | 82832860021 | Teste de Gravidez (hCG) - Tiras 10mUI/mL | Class II |
| BR | 82832860022 | Teste de Gravidez (hCG) - Midstream 10mUI/mL | Class II |
| BR | 82832860023 | Teste de Gravidez (hCG) - Tiras 25mUI/mL | Class II |