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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | 2010-08-27 |
| US | K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | 2006-01-26 |
| US | K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | 2005-08-30 |
| BR | 10349000744 | KIT KYPHOPAK KPT1005 - CDS | Class II |
| BR | 10349000746 | KIT KYPHOPAK KPT1001 | Class II |
| CA | 5717 | RE-USABLE BIOPSY INSTRUMENTS | Class I |
| CA | 5719 | ULTRA-VAC ADJUSTABLE AUTOMATED ASPIRATION BIOPSY SYSTEM | Class II |
| CA | 5720 | ULTRA-CUT ADJUSTABLE AUTOMATED BIOPSY SYSTEM | Class II |