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EUDAMED last updated this device on May 3, 2022
376035797N4DL2NICRALLIUM N4 DISQUE Ø98,5x18MM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by BERNARD CERVOS SOCIETE. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
FR-MF-000016213(01)03760357971237
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 France; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | May 3, 2022 | May 3, 2042 |
| Belgium | May 3, 2022 | May 3, 2042 |
| Germany | May 3, 2022 | May 3, 2042 |
| Spain | May 3, 2022 | May 3, 2042 |
| Italy | May 3, 2022 | May 3, 2042 |
| Netherlands | May 3, 2022 | May 3, 2042 |
| Poland | May 3, 2022 | May 3, 2042 |
| Portugal | May 3, 2022 | May 3, 2042 |
| Romania | May 3, 2022 | May 3, 2042 |
| Slovakia | May 3, 2022 | May 3, 2042 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03760357971237Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
376035797N4DL20130459818UDI 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.
Q010601DENTAL ALLOYSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
376035797N4DL2On the marketNICRALLIUM N4 DISQUE Ø98,5x16MM376035797N4DL2On the marketNICRALLIUM N4 DISQUE Ø98,5x17MM376035797N4DL2On the marketNICRALLIUM N4 DISQUE Ø98,5x19MM376035797N4DL2On the marketNICRALLIUM N4 DISQUE Ø98,5x20MM376035797N4DL2On the marketNICRALLIUM N4 DISQUE Ø98,5x22MM376035797N4DL2On 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.