This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Israel, Russia — 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 |
|---|---|---|---|
| US | K863916 | CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM | 1987-01-06 |
| US | K863917 | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. | 1987-01-06 |
| US | K852791 | 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS | 1985-11-05 |
| BR | 80076800015 | HYDRA 18VLS: HYDRA AORTIC VALVE LOADING SYSTEM (AVLS) | Class I |