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 | K023450 | BIOPSY SITE TISSUE MARKER DEVICE | 2002-12-19 |
| US | K022634 | CO-AXIAL INTRODUCER NEEDLE | 2002-11-06 |
| US | K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE | 2001-07-24 |
| CA | 1010 | BIOPSY GUN | Class II |
| CA | 7617 | CORE NEEDLE BIOPSY SET | Class II |