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DRI OCT Triton (plus)
EUDAMEDClass IIa (EU MDR)
Ref 3D OPTICAL COHERENCE TOMOGRAPHY
Identity
- Trade Name
- DRI OCT Triton (plus) EUDAMED
- Device Name
- 3D Optical Coherence Tomography EUDAMED
- Model / Reference
- 3D OPTICAL COHERENCE TOMOGRAPHY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130283442 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
DRI OCT Triton (plus) by Topcon Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 5d68706a-8338-416d-9713-e41acb60c9d7 61 fields · synced Jul 8, 2026