This company has registrations in United States, Canada, Israel — 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 | K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | 2017-03-14 |
| US | K122294 | PRESSURIZED INFUSION PUMP | 2012-11-01 |
| US | K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM | 2012-06-21 |
| CA | 4338 | ANORECTAL MANOMETRIC CATHETERS | Class II |
| CA | 7562 | PEDIATRIC MANOMETRIC CATHETER | Class II |
| CA | 72714 | MOTILITY VISUALIZATION SYSTEM | Class II |