- Role
- Country
- Date of registration
- Address
JP-MF-000003928No 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.COMPUTERIZED TONOMETER CT-800 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by TOPCON CORPORATION. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 9, 2025
4560126260030TYPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04560126268150
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
Preventing Fire and Electric Shock： 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./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./ To avoid electric shock, 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. /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./ Modification of this instrument is not permitted.
OTHER
OTHER
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Netherlands; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04560126268150Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4560126260030TYCT-800UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120122TONOMETERSB-04562123285642On the marketCOMPUTERIZED TONOMETER CT-1P4560126260030TYOn the marketCOMPUTERIZED TONOMETER CT-800B-04562123287370On the marketCOMPUTERIZED TONOMETER CT-800AB-04562123287851On the marketCOMPUTERIZED TONOMETER CT-800A4560126260030TYOn the marketDIGITAL CAMERA UNIT DC-44560126260101TWOn the marketNo certificate specifically references this device's Basic UDI-DI.