- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 25, 2023
++B961DDPD3365LKFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 2 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Daddy D Pro. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
B961DDPD33650DDP-D3-365PK-MF-000035172No 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.B961DDPD33650
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
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 Portugal; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Poland | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q01010101AMALGAMS FOR RESTORATIVE DENTISTRYPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →++B961DDPD3364LHOn the marketFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 1 NYU/B2++B961DDPD3358LNOn the marketFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 1 WESTCOTT N.21++B961DDPD3359LQOn the marketFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 2 LADMORE++B961DDPD3362LDOn the marketFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 2 WESTCOTT N.21B++B961DDPD3360L9On the marketFILLING INSTRUMENTS AMALGAM INSTRUMENTS AND BURNISHERS 3++B961DDPD3366LMOn the marketNo certificate specifically references this device's Basic UDI-DI.