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JP-MF-000003928COMPU VISION CV-5000 is an EU MDR-regulated 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.
EUDAMED last updated this device on Jan 16, 2025
4560126260110TXPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04560126268518
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
Ensuring the Safety of Patients and Operators: Be careful not to bump the patient's eyes or nose with the instrument during operation. The patient may be injured.Preventing Electric Shocks and Fires./ To avoid fire and electric shock, install the instrument in a 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 shock, do not insert metal objects into any openings, etc./ To avoid fire in the event of an instrument malfunction, immediately turn off the power switch and unplug the cable if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for repairs. Modification of this instrument is not permitted./ To avoid electric shock and fire, do not disassemble, modify or repair the equipment. Ask your dealer for repairs. Electoric shock may cause bums or a possible fire. Turn the power switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating. / To avoid injury caused by electric shock, do not open the cover. Ask your dealer for service./ To avoid fire and electric shock in case of leakage, be sure to use a grounded outlet. Do not connect to outlets that are not grounded./ To avoid electric shock, be sure to remove the power cord from the instrument body before removing the fuse cover for replacement. Also, do not connect the power cord to the instrument body with the fuse cover left unfixed./ To avoid fire in the event of an instrument malfunction, use a properly rated fuse.
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.
04560126268518Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4560126260110TXCV-5000UDI 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.
Z1212012001VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT4560126260101TWOn the marketCOMPU VISION CV-50004560126260110TXOn the marketCOMPU VISION CV-50004560126260110TXOn the marketCOMPU VISION CV-50004560126260110TXOn the marketCOMPUTERIZED TONOMETER CT-1B-04571130282582On the marketCOMPUTERIZED TONOMETER CT-14560126260030TYOn the marketNo 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.