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EUDAMED last updated this device on Jun 24, 2024
4560126260500UGREFRACTION SYSTEM Chronos is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by TOPCON CORPORATION. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04560126268341Chronos(01)04560126268341
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120115OPTOMETERS2 warnings recorded — scroll inside the panel to see all entries.
To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.; 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.; Do not attempt disassembling, rebuilding and/or repairs on your own. To avoid electric shock and fire. Your eyes may be exposed to Class 3B invisible laser radiation. Ask your dealer for repairs.; Do not use the instrument under the condition that there is build-up of dust and liquid on power inlet, power connector and power plug. If you use the instrument with dust, fire may occur.; 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
JP-PR-000041957The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.