- Organization name
- UDI-DI code
- Reference / catalog number
JP-MF-000003928AUTO CHART PROJECTOR ACP-8(Type: EM) 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)04562123289435
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
[Preventing Electric Shocks and Fires.] To avoid electric shock, do not open the covers. Request service from an authorized Topcon distributor. / To prevent an electric shock and fire hazard, do not allow water or other foreign matter to enter into the instrument. / To avoid fire and electric shock in the case of tumbling, do not place a cup or vessel containing water/fluid on the instrument. / To avoid electric shock, do not insert objects or metals through the vent holes or gaps or place them inside the machine body. / Electric shock may cause burns 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. / Use only attached fuses (For 100, 120V range: T1.6AL 250V For 220, 230, 240V range: T1AL 250V). Using other fuses may cause a fire in the event that the instrument fails. / 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. / Do not disassemble, modify or repair the equipment. Doing so can cause electric shock or fire. Request a repair from your dealer. / 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.
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.
04562123289435Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4560126260120U2ACP-8 (Type:EM)UDI 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 EQUIPMENTNo certificate specifically references this device's Basic UDI-DI.
4560126260041U5On the marketAUTO CHART PROJECTOR ACP-8(Type: EM)4560126260120U2On the marketAUTO CHART PROJECTOR ACP-8(Type: EM)4560126260120U2On the marketAUTO CHART PROJECTOR ACP-8(Type: EM)4560126260120U2On the marketAUTO KERATO-REFRACTO TONOMETER TRK-2PB-JPMF3928_418529900JEOn the marketAUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA4560126260010TSOn the marketNo 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.