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FR-MF-000007556Classic by RISKONTROL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by ACTEON MANUFACTURING. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 11, 2022
376024300riskontrolSHPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760243000522
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
Risque de contamination des patients en cas de réutilisation.
Vérifier la bonne tenue de l'embout sur l'adaptateur par un test sous pression d'air avant mise en bouche.
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 30 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | May 26, 2021 | Still on market |
| Austria | May 26, 2021 | Still on market |
| Belgium | May 26, 2021 | Still on market |
| Bulgaria | Aug 1, 2023 | Still on market |
| Cyprus | May 26, 2021 | Still on market |
| Czechia | May 26, 2021 | Still on market |
| Germany | May 26, 2021 | Still on market |
| Denmark | Aug 1, 2023 | Still on market |
| Estonia | Aug 1, 2023 | Still on market |
| EL | May 26, 2021 | Still on market |
| Spain | May 26, 2021 | Still on market |
| Finland | Aug 1, 2023 | Still on market |
| Croatia | May 26, 2021 | Still on market |
| Hungary | Aug 1, 2023 | Still on market |
| Ireland | May 26, 2021 | Still on market |
| Iceland | May 26, 2021 | Still on market |
| Italy | May 26, 2021 | Still on market |
| Liechtenstein | May 26, 2021 | Still on market |
| Lithuania | Aug 1, 2023 | Still on market |
| Luxembourg | May 26, 2021 | Still on market |
| Latvia | Aug 1, 2023 | Still on market |
| Netherlands | May 26, 2021 | Still on market |
| Norway | Aug 1, 2023 | Still on market |
| Poland | May 26, 2021 | Still on market |
| Portugal | May 26, 2021 | Still on market |
| Romania | Aug 1, 2023 | Still on market |
| Sweden | May 26, 2021 | Still on market |
| Slovenia | Aug 1, 2023 | Still on market |
| Slovakia | Aug 1, 2023 | Still on market |
| XI | May 26, 2021 | 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.
03760243000522Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
376024300riskontrolSH201667UDI 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.
Q0199ODONTOLOGY DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
376024300riskontrolSHOn the marketArt by RISKONTROL376024300riskontrolSHOn the marketClassic by RISKONTROL376024300riskontrolSHOn the marketClassic by RISKONTROL376024300riskontrolSHOn the marketClassic by RISKONTROL376024300riskontrolSHOn the marketClassic by RISKONTROL376024300riskontrolSHOn the marketCertificate health across this manufacturer's portfolio.
40031Supplemented39305SupplementedNotified 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 →