This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 | K201440 | ROTEM sigma Thromboelastometry System | 2022-07-08 |
| US | K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM | 2011-08-10 |
| BR | 80291330020 | fib-TEM S | Class II |
| BR | 80291330021 | Ap-TEM S | Class II |
| BR | 80291330022 | Hep-TEM S | Class II |