This company has registrations in United States, Brazil — 2 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 | K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | 2019-04-04 |
| US | K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | 2017-08-31 |
| US | K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 | 2013-05-06 |
| BR | 80943570002 | Agulhas Subcutâneas HIgH-Flo | Class II |