Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

1 warning 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 shock, do not insert metal objects into the instrument body through the vent holes or gaps.

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.

04571130283374

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.

4560126260050U6

Reference / catalog number

RM-800

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

AUTO REFRACTOMETER

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• -10–10 MU104
• 0–180 MU105
• PD measurement — 20–85 MU50
• -25–22 MU104

• 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.