- 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.PIXELCHART PC-50 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 Nov 7, 2024
4560126260120U2Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04571130282063
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.
[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 vessels containing liquids near the instrument. / To avoid fire and electric shock, do not insert metal objects into any clearance, etc. / To avoid fire in the event of an instrument malfunction, immediately turn off the power switch and remove the power plug from the outlet 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. / To avoid electric shock and fire, do not disassemble, modify or repair the equipment. Ask your dealer for repairs. / To avoid electric shock, do not remove the cover. Contact your local authorized dealer or Topcon office (listed in back cover) to repair the instrument. / To avoid fire or electric shock, turn off the power switch, remove the power cord from the outlet and then replace the fuse with the rated one. / 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 fire or electric shock, turn off the power of the instrument and remove the power plug from the outlet before inspecting or cleaning the instrument and replacing the 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.
04571130282063Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4560126260120U2PC-50UDI 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 EQUIPMENT4560126260080UFOn the marketOPHTHALMIC DATA SYSTEM IMAGEnet 74560126260080UFOn the marketPARALLEL BINOCULAR TUBE PB-24560126260101TWOn the marketREFRACTION SYSTEM Chronos4560126260060U9On the marketREFRACTION SYSTEM Chronos4560126260060U9On the marketREFRACTION SYSTEM ChronosB-JPMF3928_1037591-03YHOn the marketNo certificate specifically references this device's Basic UDI-DI.