This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 | K232999 | Lyric4 Hearing Aid | 2024-04-11 |
| US | K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | 2023-06-16 |
| BR | 81778819072 | Aparelho Auditivo Retroauricular Plataforma Marvel | Class II |
| BR | 10283319016 | Aparelho auditivo Unitron Moxi B | Class II |
| BR | 10283310179 | Receptor Roger | Class II |
| CA | 87045 | FITTING SOFTWARE | Class II |
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