This company has registrations in United States, Brazil, Israel, Russia — 4 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.
Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K110520 | BIOLIS 12I | 2012-03-23 |
| US | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | 2011-12-01 |
| US | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | 2005-02-15 |
| BR | 10009010355 | Família LABMAX i | Class II |
| BR | 10009010181 | FAMÍLIA LABMAX | Class II |
| BR | 10269360293 | FAMÍLIA DE ANALISADORES AUTOMÁTICOS DE BIOQUÍMICA | Class II |