This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 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 | K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | 2019-12-18 |
| US | K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) | 2017-02-06 |
| BR | 80071260417 | Sistemas de Amostragem de Gases Respiratório | Class II |
| BR | 80071260418 | Sondas de Temperatura Reutilizáveis | Class II |
| CA | 75728 | TEMPERATURE PROBES - REUSABLE AND DISPOSABLE | Class II |
| CA | 75729 | BLUETEMP INTERFACE CABLES | Class II |