Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

• CW259

  To avoid injury caused by electric shock, do not open the cover. Ask your dealer for service. To avoid electric shock, do not handle the power plug with wet fingers. To avoid electric shock, do not touch the external connection terminal and the patient at the same time.

Primary placement in Netherlands; available across 32 countries total.

Trade name

AUTO KERATO-REFRACTOMETER KR-800

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.

04571130283350

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.

4560126260060U9

Reference / catalog number

KR-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 KERATO-REFRACTOMETER

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• -10–10 MU104
• -25–22 MU104
• 0–180 MU105
• 5–10 MU50
• PD measurement — 20–85 MU50

• 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.