This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel — 7 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 |
|---|---|---|---|
| CA | 65540 | PRISMA FLEX SETS | Class III |
| CA | 82780 | PRISMAFLEX ADSORBA KITS | Class III |
| CA | 83050 | SEPTEX (EXTRA CORPOREAL CIRCUIT) | Class III |