Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

• Warning; Electricity

  [Preventing Electric Shocks and Fires] To avoid fire and electric shock in case of leakage, be sure to use a grounded outlet. Do not connect to outlets that are not grounded. To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " ○ " and disconnect the power cord from the instrument if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power cord from the instrument. Ask your dealer for service engineer. Do not disassemble, modify or repair the equipment. Doing so can cause electric shock or fire. For repairs, call your dealer. Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding. Connection to a receptacle without grounding may cause fire and electric shock in the case of shortcircuiting.

• [Ensuring the Safety of Patients and Operators] /Use this instrument carefully on the following patients: • Patients who have epidemic corneitis, conjunctivitis or any other infectious disease. • Patients who are taking medications that cause light hypersensitivity. /When operating the instrument, be sure not to touch the patient's eye or nose. /To avoid injury or fire caused by electric shock, turn off the power switch and unplug the power cord when not in use.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

SLIT LAMP SL-2G

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.

04562123289527

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.

4560126260100TU

Reference / catalog number

SL-2G

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

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.

• Z12120108SLIT LAMPS

• Class I medical devices in EUDAMED

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