This company has registrations in United States — 1 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 | K964185 | IMX CA 125 | 1997-11-04 |
| US | K972182 | ABBOTT STREP A CONTROLS | 1997-08-13 |
| US | K961439 | ABBOTT CELL-DYN 4000 SYSTEM | 1996-10-18 |