This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | 2024-04-12 |
| US | K192547 | MAGLUMI 2000 HCG/ß-HCG | 2020-01-17 |
| US | K191499 | MAGLUMI 2000 25-OH Vitamin D | 2019-08-01 |
| BR | 80102512768 | FAMÍLIA MAGLUMI® 25-OH Vitamina D (CLIA) | Class II |
| BR | 80102512943 | MAGLUMI® Controle de Imunoensaio | Class II |
| BR | 80102513632 | Família Biossays ISE Calibrators | Class II |
Signed in · open all 27 sampled records for this company and export → · Export rows left this month —/100