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3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton2
EUDAMEDClass IIa (EU MDR)
Ref DRI OCT Triton2
Identity
- Trade Name
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton2 EUDAMED
- Device Name
- 3D Optical Coherence Tomography EUDAMED
- Model / Reference
- DRI OCT Triton2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560126268303 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
A comprehensive medical device directory entry for the 3D Optical Coherence Tomography DRI OCT Triton2 device, including its key features, compliance, and FAQs.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED e51213f2-bfad-48f0-a649-b70e50aa8e75 61 fields · synced Jul 27, 2026