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3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton
EUDAMEDClass IIa (EU MDR)
Ref 470119900Model Triton
Identity
- Trade Name
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton EUDAMED
- Device Name
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton EUDAMED
- Model / Reference
- Triton EUDAMED470119900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123287509 EUDAMED
- Basic UDI-DI
- B-04562123287509 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04562123287509 | 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 5479c005-7c53-4bd6-be19-8d80d51c97db 61 fields · synced May 22, 2026