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Myopia Expert 700
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BMT1IVModel MYAH; MYOPIA EXPERT 700
Identity
- Trade Name
- MYOPIA EXPERT 700 EUDAMED
- Device Name
- MYAH EUDAMED
- Model / Reference
- MYAH; MYOPIA EXPERT 700 EUDAMEDBMT1IV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034028770395 EUDAMED
- Basic UDI-DI
- 803402877BIOMETER2C7 EUDAMED
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Myopia Expert 700 by Visia Imaging Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211868 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222933 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 803402877BIOMETER2C7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
Sources (2)
- EUDAMED 68ca5eed-a2ee-4ae0-a7ca-ad1581493e5f 61 fields · synced Jul 8, 2026
- FDA 510(k) K211868 1 fields · synced May 18, 2026