This company has registrations in United States, Brazil, Canada, Australia — 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 | K110384 | DILON 6800 ACELLA (ACELLA) | 2011-05-03 |
| US | K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | 2009-12-11 |
| US | K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 | 1999-03-16 |
| BR | 81194869005 | Bougie descartável CoPilot VL® | Class II |
| BR | 81194860012 | Lâmina descartável Co-Pilot VL | Class II |
| CA | 88974 | DILON 6800 GAMMA CAMERA | Class II |
| CA | 89011 | DILON 6800 ACELLA GAMMA CAMERA | Class II |
| CA | 89141 | GAMMALOC SYSTEM | Class II |