- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 18, 2023
++B961DDPD2343L2ROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPS 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.B961DDPD23430
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 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
B961DDPD23430Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++B961DDPD2343L2DDP-D2-343UDI 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.
Q010399SURGICAL DENTAL DEVICES - OTHERPrimary 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.
++B961DDPD2339LBOn the marketROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPS++B961DDPD2337L7On the marketROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPS++B961DDPD2344L4On the marketROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPS++B961DDPD2340KUOn the marketROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPSB961DDPD23360++B961DDPD2336L5On the marketROOTS ELEVATORS LUXATOR ELEVATORS SET OF 8 PCS- BLUE TITANIUM COATED TIPSB961DDPD23380++B961DDPD2338L9On the market