Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

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

• Warning; Electricity

  Preventing Fire and Electric Shock: To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids./ To avoid electric shock, do not insert metal objects into the instrument body through the vent holes or gaps./ To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument. Electric shock may cause burns or a possible fire. Turn the POWER switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating./ To avoid electric shock, burns and fire, turn the power switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating./ Always use the attached fuse (T 3AL 250V). Using any other type may cause malfunction and/ or fire. / To avoid fire in the event of an instrument malfunction, immediately turn OFF the POWER switch " " and disconnect the power plug from the outlet if you see smoke coming from the instrument, etc. Don't install the ins

• Caution

  To avoid electric shock, do not handle the plugs with wet fingers. / Do not to connect additional a power strip (it shall be not only in patient environment also in outside of patient environment).

Primary placement in Netherlands; available across 32 countries total.

Trade name

not provided

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.

04560126268563

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.

4560126260111TZ

Reference / catalog number

1 DIAL CONTROLLER KB-50S

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

Product code 1074736-02 (Windows 10, Pure white color)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z1212012001VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT

• Class I medical devices in EUDAMED