This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel — 6 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 | K181660 | Acapella Choice Blue Vibratory PEP Device | 2019-10-24 |
| US | K123957 | PNEUPAC PARAPAC PLUS | 2013-09-16 |
| US | K071527 | PNEUPAC VR1 AIR MIX | 2007-10-04 |
| BR | 10150470072 | CONECTOR PORTEX | Class II |
| BR | 10150470005 | CANULA DE GUEDELL PORTEX | Class II |
| BR | 10150470006 | CANULA PARA TRAQUEOSTOMIA PORTEX | Class II |
| SA | ME0000005837SFDAA00001 | Portex Venn Reusable Tracheal Tube Introducer | — |
| SA | ME0000005837SFDAA00002 | Portex Tracheal Tube Exchange Guide | — |
| CA | 12848 | GRASEBY 9000 SERIES - AMBULATORY INFUSION PUMP | Class III |
| CA | 66746 | OPTIVA PERIPHERAL INTRAVASCULAR CATHETERS | Class II |
| CA | 66745 | JELCO 2 INTRAVASCULAR CATHETERS | Class II |