This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.
Australia, 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 | K133308 | TINNITUS SOUNDSUPPORT | 2014-03-18 |
| US | K951002 | AMENDMENTS TO MULTIFOCUS | 1995-09-18 |
| BR | 10356029004 | STREAMER PRO | Class II |
| BR | 10356020077 | APARELHO AMIGO DE AMPLIFICAÇÃO SONORA | Class II |
| BR | 10356029003 | STREAMER | Class II |
| CA | 99825 | HEARING AID BATTERIES | Class II |
| CA | 102684 | OTICON ON | Class II |
| CA | 103655 | OTICON REMOTECARE APP | Class II |
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