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 | K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | 2000-07-12 |
| US | K943153 | MICROSAMPLE COAGULATION ANALYZER | 1995-03-24 |
| US | K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | 1989-06-23 |
| BR | 80174889003 | KIT DE SERINGA PARA INJETORA DE CONSTRASTE BIO-DATA | Class II |
| BR | 80174889014 | KIT SERINGA 200 ML BIO-INJECT BIO-DATA | Class II |
| BR | 80174889009 | PERFURADOR PUNCH BIO-DATA | Class II |