This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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 | K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | 2021-11-04 |
| US | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | 2021-07-02 |
| US | K202205 | Surgical Face Mask | 2021-03-09 |
| BR | 82930219009 | Agulha Hipodérmica Estéril para Uso Único com dispositivo de segurança | Class II |
| BR | 82930219010 | Agulha Hipodérmica Estéril para Uso Único sem dispositivo | Class II |
| BR | 82930219011 | Seringa Hipodérmica de Insulina com Dispositivo | Class II |
| CA | 106665 | ENTERAL / ORAL SYRINGE | Class II |
| CA | 108305 | STERILE COMPOUNDING SYRINGE | Class II |