Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

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

• CW999

  CONTRAINDICATION/PROHIBITION Ensuring the Safety of Patients and Operators To prevent corneal damage, do not measure a patient with corneal disease or one who's had corneal surgery. To prevent corneal damage, do not measure a patient wearing a contact lens. Tell the patient to remove the contact lens.
• CW999

  WARNING Ensuring the Safety of Patients and Operators When operating the instrument, do not touch the patient's eye or nose. Handling the cord on this product or cords associated with accessories sold with this product, will expose you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after handling. Preventing Electric Shocks and Fires 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 shocks, do not insert metal objects into the instrument body through the vent holes or gaps. To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and disconnect the power plug from the outlet if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for service.
• CW999

  CAUTION Important caution The following patients need extra attention. • Patients with infectious disease such as Keratoconjunctivitis Epidemica Ensuring the Safety of Patients and Operators Be sure to perform setting of safety stopper, to avoid injury caused by the instrument hitting the patient's eye or nose. To avoid injury when operating the up/down button for chinrest, be careful not to catch the patient's fingers. To avoid injury when operating the measuring head up or down, be careful not to catch the patient's/operator's fingers. When operating the instrument use much care so that operator's finger or hand is not pinched between the forehead rest and the main body. Or the operator may be injured. Preventing Electric Shocks To avoid injury by electric shock, do not open the cover. For repair, call your service engineer.

Primary placement in Netherlands; available across 32 countries total.

Trade name

COMPUTERIZED TONOMETER CT-800A

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.

04562123287851

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.

B-04562123287851

Reference / catalog number

CT-800A

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

MDD [Directive 93/42/EEC 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

• 1–60 MU51

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

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

• Z12120122TONOMETERS

• Class IIa medical devices in EUDAMED

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