Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

OPHTHALMIC DATA SYSTEM IMAGEnet 7

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.

04560126268976

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.

4560126260080UF

Reference / catalog number

IMAGEnet 7

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 IIa

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

• Measures the length and area of the region surrounded by a line or rectangle.
• the ratio of “Cup” and “Disc” (C/D ratio) on optic disc according to the range specified by mouse operation.

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

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

• Z12120192OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

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