- Role
- Country
- Date of registration
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EUDAMED last updated this device on Jul 25, 2023
++B961DDPD3339LJFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS 4Z SERRATED 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.
PK-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.B961DDPD33390
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA 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 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
B961DDPD33390Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++B961DDPD3339LJDDP-D3-339UDI 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.
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 →No certificate specifically references this device's Basic UDI-DI.
++B961DDPD3338LGOn the marketFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS 4++B961DDPD3351L8On the marketFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS 4 SMOOTH++B961DDPD3335LAOn the marketFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS 5++B961DDPD3352LAOn the marketFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS HOLLENBACK H1 1.65MMFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS HOLLENBACK H1 1.65MMFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS HOLLENBACK H1 1.65MM++B961DDPD3323L3On the marketFILLING INSTRUMENTS AMALGAM AND PLASTIC INSTRUMENTS HOLLENBACK H2 2.7MM++B961DDPD3324L5On the market