This company has registrations in United States, Canada — 2 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 | K033017 | PHOENIX INFUSION CATHETER | 2004-04-07 |
| US | K030468 | ACURA ELITE GRAVITY COMPENSATING RESERVOIR | 2003-10-15 |
| US | K024101 | PHOENIX UNIVERSAL SHUNT SYSTEM | 2003-01-27 |
| CA | 92481 | PAB LYME EIA | Class II |
| CA | 97630 | ATHAL RAPID SCREEN | Class II |
| CA | 103181 | ULTRA-SENSITIVE AMH/MIS ELISA | Class II |