- Role
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US-MF-0000085052084956CE01PlasmaJet is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Plasma Surgical, Inc.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 29, 2022
B-PlasmaJetRLPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-PlasmaJetRL
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 France; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Dec 26, 2008 | Still on market |
| Austria | Jul 1, 2013 | Still on market |
| Belgium | Dec 6, 2010 | Still on market |
| Czechia | Apr 10, 2015 | Still on market |
| Germany | Feb 28, 2013 | Still on market |
| Denmark | Sep 22, 2017 | Still on market |
| Spain | Jun 2, 2017 | Still on market |
| Finland | Oct 30, 2020 | Still on market |
| Ireland | Dec 29, 2020 | Still on market |
| Italy | Nov 2, 2009 | Still on market |
| Netherlands | Feb 14, 2012 | Still on market |
| Poland | Jun 25, 2013 | Still on market |
| Romania | Dec 30, 2014 | Still on market |
| Sweden | May 25, 2011 | Still on market |
| Türkiye | Mar 17, 2011 | Still on market |
| XI | Jun 12, 2013 | 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-PlasmaJetRLBasic 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-PlasmaJetRLPlasmaJetUDI 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.
K020499DEVICES FOR SURGERY WITH ARGON GAS GENERATOR, SINGLE-USE - OTHERNo certificate specifically references this device's Basic UDI-DI.
No 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.