- Role
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- Date of registration
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DE-MF-000009412D1418500005Extraction Tool is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by MEDIGMA BIOMEDICAL GMBH. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 21, 2022
B-DEMF000009412MGST00356MPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-DEMF000009412MGST00356M
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 Türkiye; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Jun 27, 2017 | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| XI | — | 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.
D-DEMF000009412MGST00356MBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-DEMF000009412MGST00356MMGST0035UDI 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.
L80SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIESNo certificate specifically references this device's Basic UDI-DI.
B-DEMF0000094122532DM22On the marketExtra Long Twist Step Drill 3.2/3.6mmD x 16-25mmLB-DEMF0000094122536DM2NOn the marketExtra Long Twist Step Drill 3.2/3.6mmD x 16-25mmL426052516TwistStepDrill8ZOn the marketExtraction Tool426052516GuideSurgerTol3ZOn the marketExtraction Tool Spanner426052516GuideSurgerTol3ZOn the marketExtraction Tool SpannerB-DEMF000009412MGST00366POn 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.