This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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 | K223542 | TubaVent Balloon Dilatation System | 2023-08-03 |
| BR | 81363880020 | CATETER AERIS COM BALÃO DE DILATAÇÃO DAS VIAS AÉREAS, ESTÉRIL E DESCAR | Class I |
| BR | 81363880021 | CATETER BALÃO TUBAVENT SHORT PARA DILATAÇÃO DA TROMPA DE EUSTÁQUIO | Class I |
| BR | 80926150055 | Tampão Nasal Expanding Spiggle - PVA - Com Via Aérea | Class I |
| SA | ME0000006233SFDAA00036 | HF-Cables | — |
| SA | ME0000006233SFDAA00037 | Endoscope Handle | — |
| CA | 88455 | SEPTAL BUTTONS | Class II |
| CA | 88456 | SAW BLADES (OSCILLATING INSTRUMENTS) | Class II |
| CA | 89625 | MIDDLE EAR DRAINAGE AND VENTILATION TUBE MADE FROM PTFE | Class III |