This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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 |
|---|---|---|---|
| US | K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe | 2014-12-12 |
| US | K133446 | HEPARIN LOCK / FLUSH SYRINGES | 2014-11-14 |
| US | K130975 | SWABCAP AND SWABFLUSH | 2013-12-24 |
| CA | 81366 | 30% ETHANOL AND 4% SODIUM CITRATE | Class II |
| CA | 83102 | HEPARIN FLUSH, USP 1000 UNITS/ML ONLY FOR FLUSHING CIRCUITS IN HEMODIALYSIS MACHINES | Class II |