This company has registrations in United States, Brazil, Taiwan, Israel, Russia — 5 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 | K071648 | EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS | 2007-08-22 |
| US | K043070 | LIQUID STABLE HBA1C CONTROL | 2004-12-09 |
| US | K021484 | HEMOGLOBIN A1C CONTROL | 2002-06-14 |
| BR | 80915630003 | HbA1c CONTROL SET | Class II |
| BR | 10033120956 | HbA1c Liquid Controls | Class II |