This company has registrations in United States, Canada — 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 | K173439 | Bloom2 Programmable Electrophysiology Stimulator | 2018-03-29 |
| CA | 78475 | DTU-215B EPSTIM SYSTEM | Class III |
| CA | 79271 | VERSARAD-A RADIOGRAPHIC SYSTEM | Class II |
| CA | 110769 | BLOOM2 CARDIAC STIMULATOR SYSTEM | Class III |