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3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus)

FDA UDIEUDAMED

Class II (US FDA UDI)

by Topcon Corp.

Identity

Trade Name
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) FDA UDI
Generic Name
Retinal optical coherence tomography system FDA UDI
Model / Reference
DRI OCT Triton(plus) FDA UDI

Identifiers

Primary DI / UDI-DI
04562123289046 FDA UDI
FDA Product Code
HKI FDA UDI
OBO FDA UDI
GMDN Term
Retinal optical coherence tomography system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1120 FDA UDI
886.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Retinal optical coherence tomography system

3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) by Topcon Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Retinal optical coherence tomography system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Topcon Corp.

Sources (2)

  • FDA UDI e28bf35f-6dd6-49fd-b3af-c24a8c1995e8 32 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026