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JP-MF-000011382Nu:le Coat Liquid Blue 4ml 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.
EUDAMED last updated this device on Feb 27, 2024
456023117D10B103N001V6Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04560231179150
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.
DO NOT USE THIS PRODUCT ON PATIENTS WHO HAVE A HISTORY OF ALLERGY SUCH AS IRRITATION TO THIS PRODUCT OR METHACRYLIC ACID SERIES OR METHACRYLATE MONOMER
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 Romania; available across 11 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 |
| 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.
04560231179150Basic 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 - OTHERNo certificate specifically references this device's Basic UDI-DI.
456023117D10B103N001V6On the marketNu:le Coat Liquid B plus 4ml456023117D10B103N001V6On the marketNu:le Coat Liquid Black 4ml456023117D10B103N001V6On the marketNu:le Coat Liquid Brown 4ml456023117D10B103N001V6On the marketNu:le Coat Liquid C plus 4ml456023117D10B103N001V6On the marketNu:le Coat Liquid Clear 6ml456023117D10B103N001V6On 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.