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DE-MF-000009201CL 049319 0010Barrel Cutter, Barrel Tip, with distal protection is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Joimax GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 24, 2024
B-04250337103127Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04250337103127
5 warnings recorded — scroll inside the panel to see all entries.
CW032CW010CW009CW007CW001Sterile
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 Germany; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Aug 23, 2010 | Still on market |
| Austria | Sep 20, 2016 | Still on market |
| Belgium | Aug 30, 2010 | Still on market |
| Bulgaria | Apr 15, 2011 | Still on market |
| Czechia | Aug 23, 2010 | Still on market |
| Denmark | Aug 30, 2010 | Still on market |
| EL | Aug 30, 2010 | Still on market |
| Spain | Dec 9, 2010 | Still on market |
| France | Apr 9, 2021 | Still on market |
| Croatia | Aug 23, 2010 | Still on market |
| Ireland | Aug 30, 2010 | Still on market |
| Italy | Oct 1, 2021 | Still on market |
| Luxembourg | Aug 30, 2010 | Still on market |
| Netherlands | Dec 29, 2011 | Still on market |
| Norway | Aug 30, 2010 | Still on market |
| Poland | Aug 23, 2010 | Still on market |
| Portugal | Aug 23, 2010 | Still on market |
| Romania | Aug 23, 2010 | Still on market |
| Türkiye | Aug 23, 2010 | 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.
04250337103127Basic 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-04250337103127JSBBC3235UDI 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.
Z12130585MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLESCertificate health across this manufacturer's portfolio.
G10 049319 0007SupplementedG11 049319 0011IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →42503371AWLAWLD6On the marketBall Handle for Reamer42503371REAMHDQOn the marketBarrel Cutter, Barrel Tip, with distal protection42503371DEFLRESAKOn the marketBiopsy Forceps, Blakesley42503371FORCGRAG8On the marketBiopsy Forceps, BlakesleyB-04250337100133On the marketBiopsy Forceps, BlakesleyB-04250337101963On the marketNo certificate specifically references this device's Basic UDI-DI.