Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

• Warning; Electricity

  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 electric shocks, do not insert metal objects into the instrument body through the vent holes or gaps./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. Don't install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for service./Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding. Connection with receptacle without grounding may cause fire and electric shock in case of short-circuiting./Always use the attached fuse (T 3AL 250V). Using any other type may cause malfunction and fire./Connect only items that have been specified as part of the ME system or that have been specified as being compatible with the ME system./Modification of this instrument is not permitted.

• Connect only items that have been specified as part of the ME system or that have been specified as being compatible with the ME system.

  OTHER

• Ensuring the Safety of Patients and Operators: Be careful not to hit the patient's eyes or nose with the instrument during operation.

  OTHER

• Proposition65 warning sentence: This product can expose you to chemicals including Lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

AUTO KERATO-REFRACTOMETER KR-1

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.

04571130283381

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.

4560126260060U9

Reference / catalog number

KR-1

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 I

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

• -25–22 MU104
• -10–10 MU104
• 0–180 MU105
• Cornea curvature radius — 5–10 MU50
• Corneal refractive power — 33.75–67.5 MU104
• Corneal cylindrical power — 0–10 MU104
• Direction of corneal cylindrical axis — 0–180 MU105
• PD measurement — 20–85 MU50

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

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

• Z12120115OPTOMETERS

• Class I medical devices in EUDAMED

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