This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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 |
|---|---|---|---|
| EU | 04049059550476 | — | Class IIa |
| EU | 04049059516458 | — | Class IIa |
| EU | 04049059516441 | — | Class IIa |
| EU | 04049059300699 | — | Class IIb |
| UK | 60341 | Medical Laser | Class IIb |
| UK | 61474 | General/multiple surgical laser system beam guide, reusable | Class IIa |
| UK | 62600 | General/multiple surgical laser system beam guide, single-use | Class IIa |
| US | K250504 | Leonardo Duster | 2025-07-14 |
| US | K210951 | Leonardo Mini Blue | 2021-09-01 |
| BR | 80655350010 | Instrumento de Ressectoscopia | Class I |
| BR | 80655350009 | Bainha Laparoscópica | Class I |