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OPHTHALMIC DATA SYSTEM IMAGEnet 6
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref IMAGEnet 6
Identity
- Trade Name
- OPHTHALMIC DATA SYSTEM IMAGEnet 6 EUDAMED
- Device Name
- OPHTHALMIC DATA SYSTEM EUDAMED
- Model / Reference
- IMAGEnet 6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130282711 EUDAMED
- Basic UDI-DI
- 4560126260080UF EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
OPHTHALMIC DATA SYSTEM IMAGEnet 6 by Topcon Corporation — 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 | K171370 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232828 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4560126260080UF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (2)
- EUDAMED f626ce66-9d65-482a-9d06-85df134f2dbe 61 fields · synced Jul 21, 2026
- FDA 510(k) K171370 1 fields · synced May 18, 2026