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 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 fire in the event of an instrument malfunction, immediately turn OFF the power switch “O” 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./Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding. Connection with receptacle without grounding may cause fire and electric shock in case of short circuiting./Connect only items that have been specified as part of the ME system or that have been specified as being compatible with the ME system./Do not disassemble, modify or repair the equipment. Doing so can cause electric shock or fire.

• Connect only items that have been specified as part of the ME system or that have been specified as being compatible with the ME system.

  OTHER

• Ensuring the Safety of Patients and Operators: Be careful not to hit the patient's eyes or nose with the instrument during operation.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

SPECULAR MICROSCOPE SP-1P

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.

04571130283466

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.

4560126260070UC

Reference / catalog number

SP-1P

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

• Corneal thickness — 0.4–0.75 MU50

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

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

• Z12120110CORNEAL CONFOCAL MICROSCOPES

• Class IIa medical devices in EUDAMED

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