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EUDAMED last updated this device on Mar 30, 2026
456023117D10B103N001V6Nu:le Coat Complete Set is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by YAMAKIN CO., LTD.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
JP-MF-000011382(01)04570110515221
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.
CW018Sterile
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 Romania; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Latvia | — | Still on market |
| Poland | — | Still on market |
| Slovakia | — | 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.
04570110515221Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
456023117D10B103N001V6Nu:le CoatUDI 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.
Q010299PROSTHETIC DENTISTRY DEVICES - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →456023117D12B102N001W9On the marketKZR-CAD Zirconia Laxio GR-A3.5 φ98.5×t22456023117D12B102N001W9On the marketKZR-CAD Zirconia Laxio GR-A3.5 φ98.5×t26456023117D12B102N001W9On the marketNu:le Coat Gum Set456023117D10B103N001V6On the marketNu:le Coat Shade Plus Set456023117D10B103N001V6On the marketZEO CE LIGHT Accent 05I 25 products456023117D12B100N001VKOn 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.