Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Contraindications This instrument must not be used for the following patients: - Patients who are hypersensitive to light. - Patients who recently underwent photodynamic therapy (PDT). - Patients taking medication that causes photosensitivity.

  OTHER

• Ensuring the Safety of Patients and Operators - Be careful not to hit the patient's eyes or nose with the instrument during operation. The patient may be injured. - Modification of this instrument is not permitted. Modifying the instrument may cause people to be injured, make the burden on the human body, lower the reliability of the measurement results, or cause the devices to malfunction.

  OTHER

• Warning; Electricity

  Preventing Electric Shocks and Fires: 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. Preventing Electric Shocks: 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.

Primary placement in Netherlands; available across 32 countries total.

Trade name

DRI OCT Triton (plus)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04571130283442

Basic UDI-DI

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.

4560126260040U3

Reference / catalog number

3D OPTICAL COHERENCE TOMOGRAPHY

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Thickness of retina — 1 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12120121OPTICAL CONSISTENCY TOMOGRAPHS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.