This company has registrations in United States, Brazil, Canada — 3 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 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | 2013-12-11 |
| US | K123035 | SEAL ONE | 2012-11-28 |
| US | K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER | 2012-05-02 |
| BR | 80638240014 | Sistema de Insuflação Flamingo | Class II |
| BR | 80638240017 | Conector Y Myshell Lite | Class II |
| BR | 80638240015 | Valvy-sw | Class II |
| CA | 74743 | DOLPHIN | Class II |
| CA | 77906 | FLAMINGO SYSTEME D'INFLATION - INSTRUMENTS | Class II |
| CA | 88215 | FLAMINGO SYSTEME D'INFLATION | Class II |