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.
Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K231044 | R2P Navicross | 2023-07-27 |
| US | K213531 | TR BAND Radial Compression Device | 2021-12-20 |
| US | K193125 | R2P Destination Slender Guiding Sheath | 2020-01-06 |
| BR | 80012280192 | SOLOPATH® RE-COLLAPSIBLE - SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM | Class II |
| BR | 80012280193 | SOLOPATH® TRANSFEMORAL - SOLOPATH BALLON EXPANDABLE TRANSFEMORAL INTRO | Class II |
| BR | 80012289013 | Pinnacle Precision 4Fr a 6Fr | Class II |
| CA | 5115 | SURFLO IV CATHETER | Class II |
| CA | 5127 | TERUMO NEEDLE | Class II |
| CA | 5946 | SURFLO WINGED INFUSION DEVICE | Class II |