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3d Optical Coherence Tomography Dri Oct Triton
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DRI OCT TRITON510(k) K173119
Identity
- Trade Name
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON EUDAMED
- Device Name
- 3D Optical Coherence Tomography EUDAMED
- Model / Reference
- DRI OCT TRITON EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130283435 EUDAMED
- Basic UDI-DI
- 4560126260040U3 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS 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
3d Optical Coherence Tomography Dri Oct Triton 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173119 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4560126260040U3 | 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 49c5a2e9-ff7a-4e5b-a4da-4969a68a0762 85 fields · synced Jun 18, 2026
- FDA 510(k) K173119 1 fields · synced May 18, 2026