This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 7 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, 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 | K233464 | WSA Self-Fitting Hearing Aid Gen 2 | 2024-02-09 |
| US | K220403 | Vibe SF Self-Fitting Hearing Aid | 2022-08-12 |
| BR | 80872830001 | APARELHO AUDITIVO INTRA DIGITAL AUDIO SERVICE | Class II |
| BR | 80872830002 | APARELHO AUDITIVO RETRO DIGITAL AUDIO SERVICE | Class II |
| BR | 80872839005 | Aparelhos de Audição Intra Digital Audibel | Class II |
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