Manufacturer
Optainhealth
AustraliaLegal entities : Eyetelligence Pty Ltd, an Optain Health Company
Markets : Germany · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 1 · class II · latest in 2025 · see on the FDA website
EU representative : MedEnvoy Global BV (Netherlands)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Ophtalmology assessments and diagnosis instruments - medical device software | Z12120192 | IIa MDR | EUDAMED record Report an error |
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