Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

• CW999

  [CONTRAINDICATION] Ensuring the Safety of Patients and Operators: To prevent corneal damage, do not measure a patient with corneal disease or one who's had corneal surgery.
• CW999

  [WARNING] 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.
• CW259

  To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.; To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument.; To avoid fire in use, do not use the power inlet, power connector, or power plug with dust or liquid adhering to or accumulating on them.; To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch “O ” and disconnect the power plug from the outlet if you see smoke coming from the instrument, etc. Do not install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for service.; To avoid fire and electric shock, do not open the cover. Ask your dealer for service.; Modification of this instrument is not permitted.; If the product is used for a long period of time with the power plug plugged into the outlet, dust may collect between the outlet and the power plug, causing electric leakage due to the adhesion of water and causing a fire. Clean the space between the outlet and the power plug regularly. (There is a risk of electric leakage or fire due to the accumulation of dust and the adhesion of moisture.); To avoid injury from electric shocks, do not connect anything other than the specified external equipment to the external I/O terminals.; Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding.; Connection with recepta- cle without grounding may cause fire and electric shock in case of short-circuiting. Connect only items that have been specified as part of the ME system or that have been specified as being com- patible with the ME system.;

Primary placement in Netherlands; available across 32 countries total.

Trade name

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

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.

04571130283213

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.

4560126260010TS

Reference / catalog number

TRK-3 OMNIA

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

Product Code: 1048960-01. A variant of TRK-3 OMNIA, with different measurement range from the other variant under UDI-DI 04560126268860 (Product Code 1048960-04).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• -10–10 MU104
• 0–180 MU105
• PD measurement range — 20–85 MU50
• Cornea curvature radius — 5–10 MU50
• Corneal refractive power — 33.75–67.5 MU104
• Direction of corneal principal meridian — 0–180 MU105
• Corneal diameter — 2–14 MU50
• Intraocular pressure — 7–60 MU51
• -25–22 MU104
• Corneal thickness — 0.4–0.73 MU50

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

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

• Z12120122TONOMETERS

• Class IIa medical devices in EUDAMED

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