This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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 | K240827 | SET-5002 | 2024-05-24 |
| US | K221922 | Trinias | 2022-07-28 |
| US | K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | 2022-07-01 |
| BR | 10332340052 | CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803 | Class II |
| BR | 10175859017 | Gardian 25 mm - Filtro de Seringa | Class II |
| BR | 10175859001 | Ultipor 25 Filtro para Sistema Respiratório | Class II |
| SA | ME0000009230SFDAA00001 | Kit, Water Trap, EtCO2, 3160 | — |
| SA | ME0000004826SFDAA00011 | Pentax Laryngostroboscope | — |
| CA | 8476 | VACUUM REGULATORS | Class II |
| CA | 8494 | PEDIACTRIC AEROSOL TENT | Class II |
| CA | 8497 | INTERMITTENT SUCTION UNIT | Class II |