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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K111013 | ACEM | 2011-12-19 |
| US | K012232 | INSIGHT, MODEL S980000 | 2002-06-07 |
| US | K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | 2002-02-28 |
| BR | 80091010019 | EQUIPAMENTO DE pH AMBULATORIAL ZEPHR | Class II |
| BR | 80091010021 | EQUIPAMENTO DE MANOMETRIA INSIGHT TM G3 | Class II |
| BR | 80091010030 | Sistema inSIGHT ULTIMA | Class II |