This company has registrations in United States, Brazil, Canada, South Korea — 4 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 | K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | 2026-03-04 |
| US | K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | 2026-01-23 |
| US | K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | 2024-10-29 |
| BR | 81655639026 | Sistema de biópsia assistida a vácuo duplo | Class II |
| BR | 81655639002 | Sondas mammotome elite | Class II |
| BR | 81655639004 | Sistema de Biópsia Assistida a Vácuo Portátil | Class II |
| CA | 69195 | MICROMARK II TISSUE MARKERS WITH INTRODUCER AND APPLIER | Class III |
| CA | 75766 | MAMMOTEST BIOPSY SYSTEM | Class III |