Identity
- Trade Name
- Myopia Master EUDAMED
- Device Name
- Myopia Master EUDAMED
- Model / Reference
- 68100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049584026095 EUDAMED
- Basic UDI-DI
- 40495848BQ EUDAMED
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Myopia Master by OCULUS Optikgeräte GmbH — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202989 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 40495848BQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED 8195ab38-9212-4d1d-be68-2126cd2c97c4 85 fields · synced Jun 18, 2026
- FDA 510(k) K202989 1 fields · synced May 18, 2026