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 | K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | 2006-07-21 |
| US | K011312 | BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM | 2001-07-18 |
| US | K842022 | EEG BIOFEEDBACK DEVICE | 1984-07-20 |
| BR | 82149920003 | Kit de Extração de DNA PREP-NA-FET | Class I |
| BR | 82149920111 | Candida albicans REAL-TIME PCR Detection Kit | Class II |
| BR | 82149920112 | Família DTstream | Class I |