Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Warning; Electricity

  [Preventing Electric Shocks and Fires] To avoid electric shock and fire, do not disassemble, modify or repair the equipment. Ask your dealer for repairs./ Use only the specified lamp. Otherwise, overheating may cause a fire. / To prevent overheating, replace only with the specified type of lamp.

• [Ensuring the Safety of Patients and Operators] / Before using this instrument, make sure that the components are set and fixed securely. Falling components may cause injury or death. / Before using this instrument, adjust the balance of the 2nd arm. The microscope may move up and down suddenly, leading to injury. / When using the coaxial illumination in the ophthalmic operation, use the minimum illumination sufficient for operation. Exposing the patient's retina to excessive light may lead to retinal trouble. / Before using the instrument, make sure that the handles, screws and knobs that have red marks are tightly secured. Falling parts may cause a serious injury or death. / Before using this instrument, adjust the balance of the 2nd arm. If not, the 2nd arm may move up and down quickly and cause an injury. / When moving the instrument, do not push only the 1st arm but support the column. If you push only the upper section of the instrument, the instrument may tip over and injure persons around it. / • When loosening the 2nd arm vertical movement fixing knob, securely hold the arm end. If not the arm may suddenly move up and down and cause an injury. • Do not attach/detach accessories above a patient. Falling parts may cause a serious injury.

  OTHER

• [Proposition65 warning sentence] WARNING: This product can expose you to chemicals including LEAD, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

OPERATION MICROSCOPE OMS-90

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.

04562123289510

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.

4560126260130U5

Reference / catalog number

OMS-90

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

—

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.

• Z12011101OPERATIVE MICROSCOPES

• Class I medical devices in EUDAMED

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