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EUDAMED last updated this device on Apr 13, 2026
B-04571130282353AUTO KERATO-REFRACTOMETER KR-800 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by TOPCON CORPORATION. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04571130282353418479950(01)04571130282353
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120115OPTOMETERS2 warnings recorded — scroll inside the panel to see all entries.
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. Modification of this instrument is not permitted.
OTHER
JP-MF-000003928G2MO210200109No 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.Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
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 →B-04562123289091On the marketAUTO KERATO-REFRACTOMETER KR-8004560126260060U9On the marketAUTO KERATO-REFRACTOMETER KR-8004560126260060U9On the marketAUTO KERATO-REFRACTOMETER KR-800AB-04562123287929On the marketAUTO KERATO-REFRACTOMETER KR-800A4560126260060U9On the marketAUTO KERATO-REFRACTOMETER KR-800PA4560126260060U9On the marketNo certificate specifically references this device's Basic UDI-DI.