Is SARAH Platform certified as a medical device?
SARAH Platform by Saventic Health is listed as a CE class I medical device. Class I is self-declared by the maker, without review by a notified body. We found no FDA authorisation.
At a glance
| Product | SARAH Platform |
|---|---|
| Maker | Saventic Health |
| Care area | Other |
| What it does | AI that screens health records for patients who may have a rare disease |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| Website | saventic.com |
| Status | CE class I |
| Last checked | 7 October 2026 |
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