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US
Last updated May 23, 2026
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- US
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- EUDAMED SRN
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Earscan 3 | ES3M | FDA UDI | Class II | Active |
| Earscan 3 | ES3 | FDA UDI | Class II | Active |
| Earscan 3 | ES3S | FDA UDI | Class II | Active |
| Biometer Audiometer | K883505 | FDA 510(k) | Class II | Active |
| Dsp Screening Audiometer | K924543 | FDA 510(k) | Class II | Active |
| Earscan 3 | K982878 | FDA 510(k) | Class II | Active |
| Earscan Dsp-1 Pure Tone Audiometer | K913589 | FDA 510(k) | Class II | Active |
| Biolink Audiometer Software Accessory | K904270 | FDA 510(k) | Class II | Active |
| Earscan | K812529 | FDA 510(k) | Class II | Active |
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