This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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 | K241587 | pilot TLS | 2025-02-26 |
| US | K151237 | Nutrisafe 2- ENFit Adaptor | 2016-02-09 |
| US | K141026 | LEADERFLEX | 2014-07-30 |
| BR | 80638240004 | PROLONGADORES OCTOPUS VYGON | Class II |
| BR | 80638240005 | PROLONGADORES EM POLIURETANO OCTOPUS VYGON | Class II |
| BR | 10234400070 | SONDA PARA VENTILACAO NASAL NEONATAL | Class II |