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EUDAMED last updated this device on Sep 2, 2024
4560126260040U33D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by TOPCON CORPORATION. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04571130283435DRI OCT TRITON(01)04571130283435
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120121OPTICAL CONSISTENCY TOMOGRAPHS3 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
To avoid fire and electric shock, install the instrument in a place free of water and other liquids. To avoid fire and electric shock, do not put cups or vessels containing liquids near the instrument. To avoid fire in the event of an instrument malfunction, immediately turn OFF (○) the Power switch and unplug the cable if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to unplug the cable from the instrument body. Ask your dealer for repairs. To avoid electric shock and fire, do not disassemble. Modify or repair the equipment. Ask your dealer for repairs. To avoid electric shock, do not open the instrument. Request service from an authorized Topcon distributor. To avoid fire and electric shock in case of leakage, be sure to use a power supply equipped with a 3-pin plug AC receptacle for proper grounding. To avoid damage to the instrument or injury due to an electric shock, turn off the power switch and remove the power cord before cleaning the instrument. To avoid electric shock, do not attempt disassembling, rebuilding and/ or repairs on your own. Ask your dealer for repairs. Do not remove the covers from the main unit, chinrest unit or power supply unit except for the lamp house cover. You may receive an electric shock. Do not remove the covers from the main unit except for the lamp house cover. Your eye or skin may be exposed to the laser radiation.
JP-MF-000003928The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Aug 29, 2024 | Still on market |
| Spain | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.
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