This company has registrations in United States, Brazil, Canada — 3 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 | K200594 | Capnostream 35 Portable Respiratory Monitor | 2020-04-27 |
| US | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | 2019-03-22 |
| US | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | 2019-02-08 |
| BR | 10349000441 | Consumíveis para Capnografia Oridion Curto Prazo | Class II |
| BR | 10349000549 | Consumíveis para Capnografia Oridion Com Tubo O2 Longo Prazo | Class II |
| BR | 10349000550 | Consumíveis para Capnografia Oridion Sem Conector O2 Longo Prazo | Class II |
| CA | 12954 | MICROCAP | Class III |
| CA | 12956 | MICROCAP PLUS | Class III |