This company has registrations in United States, Brazil, Israel, Russia — 4 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 | K242793 | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | 2025-05-28 |
| US | K232529 | Disposable Double Lumen Endobronchial Tube | 2024-05-13 |
| US | K232580 | Disposable Endobronchial Blocker Tube | 2023-12-14 |
| BR | 81504799291 | Nasofaringoscópio Eletrônico | Class II |
| BR | 81504799312 | Endoscópio Brônquico Eletrônico | Class II |
| BR | 81504799314 | Vídeobroncoscópio Flexível Descartável | Class II |