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FR-MF-000016213BRASURE SECONDAIRE 3350 BAGUETTE Ø1-2MM 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.
EUDAMED last updated this device on May 9, 2022
376035797B3350BV8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760357970155
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 9, 2022 | May 9, 2042 |
| Belgium | May 9, 2022 | May 9, 2042 |
| Germany | May 9, 2022 | May 9, 2042 |
| Spain | May 9, 2022 | May 9, 2042 |
| Italy | May 9, 2022 | May 9, 2042 |
| Netherlands | May 9, 2022 | May 9, 2042 |
| Poland | May 9, 2022 | May 9, 2042 |
| Portugal | May 9, 2022 | May 9, 2042 |
| Romania | May 9, 2022 | May 9, 2042 |
| Slovakia | May 9, 2022 | May 9, 2042 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03760357970155Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
376035797B3350BV801403350UDI 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 ALLOYS376035797B3480BVWOn the marketBRASURE PRIMAIRE 3550 BAGUETTE Ø1-2MM376035797B3550BVNOn the marketBRASURE PRIMAIRE 3570 BAGUETTE Ø1-2MM376035797B3570BVYOn the marketCERABALT K21376035797K21J9On the marketCERABALT K30376035797K30JAOn the marketCERABALT K30 GRENAILLE376035797K30JAOn 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.