This company has registrations in United States, Brazil, Canada — 3 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 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | 2013-07-03 |
| US | K050983 | IRMA TRUPOINT CREATININE CONTROL KIT | 2005-05-16 |
| US | K050016 | HEMOCHRON SIGNATURE ELITE | 2005-02-10 |
| BR | 80050170016 | HEMOCHRON JR SIGNATURE PLUS | Class II |
| BR | 80050170014 | SURGICUTT APARELHO DE INCISAO PARA DETERMINACAO DE TEMPO DE COAGULACAO | Class II |
| BR | 80050170015 | TENDERFOOT APARELHO DE INCISAO PARA TESTE DO PEZINHO | Class II |
| CA | 9612 | SUPERSERUM | Class II |