Organization name

NIDEK.CO.Ltd.,

SRN

JP-MF-000040151

Manufacturer status

Active

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

• ・Be sure to use a grounded power outlet. ・Do not use the device near, on, or under other electronic equipment or electromagnetic disturbance sources. Otherwise, it could result in improper operation. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally. ・Use of accessories, cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and cause improper operation. ・ Portable RF communications equipment (including peripherals such as antenna cables and external antennas) or electromagnetic disturbance sources as shown below should be used no closer than 30 cm (12 inches) to any part of the device, including the specified or provided cables. Otherwise, degradation of the performance of this equipment could result. The following are examples of electromagnetic disturbance sources: 　・Induction cooking appliance and ovens 　・RFID readers 　・Electronic article surveillance (EAS) systems 　・Sponge detection systems 　・Equipment used for position detection (e.g. in catheter labs) 　・Wireless power transfer charging systems for electrical vehicles

  OTHER

Primary placement in XI; available across 32 countries total.

Trade name

REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III

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.

04987669100776

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.

4987669208GG

Reference / catalog number

B01E009

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

• 284 MU50
• 525 MU50
• 533 MU50
• 23 MU29

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

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

• Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
• Z1212020599MICROKERATOMY INSTRUMENTS - OTHER
• Z12120123COMPUTERISED CORNEAL TOPOGRAPHS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.