Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW259

  [Preventing Electric Shocks and Fires.] To avoid electric shock, do not open the covers. Request service from an authorized Topcon distributor. / To prevent an electric shock and fire hazard, do not allow water or other foreign matter to enter into the instrument. / To avoid fire and electric shock in the case of tumbling, do not place a cup or vessel containing water/fluid on the instrument. / To avoid electric shock, do not insert objects or metals through the vent holes or gaps or place them inside the machine body. / 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. / Use only attached fuses (For 100, 120V range: T1.6AL 250V For 220, 230, 240V range: T1AL 250V). Using other fuses may cause a fire in the event that the instrument fails. / 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 disconnect the power plug from the outlet. Ask your dealer for repairs. / Do not disassemble, modify or repair the equipment. Doing so can cause electric shock or fire. Request a repair from your dealer. / 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.

Primary placement in Netherlands; available across 32 countries total.

Trade name

AUTO CHART PROJECTOR ACP-8(Type: EM)

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.

04562123289428

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.

4560126260120U2

Reference / catalog number

ACP-8 (Type:EM)

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

F - Type Chart model with Product Code 424147757

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

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