This company has registrations in United States, Brazil — 2 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 | K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | 2026-07-10 |
| US | K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | 2026-04-03 |
| US | K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | 2025-11-25 |
| BR | 80133959015 | Linha de Sangue Extracorpórea SAVA T400807 | Class II |
| BR | 80133959016 | Linha de Sangue Extracorpórea SAVA T400808 | Class II |
| BR | 80133959017 | Linha de Sangue Extracorpórea SAVA T400806 | Class II |