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FR-MF-000007556RISKONTROL DCI 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 Jul 7, 2025
376024300adaptateurTUPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760243000089
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
Nettoyer/stériliser l’adaptateur avant sa première utilisation. Respecter le schéma de montage. L'adaptateur s'utilise uniquement avec les embouts RISKONTROL. Une fois l'adaptateur en place, vérifier sa bonne fixation sur la seringue avant l'utilisation et vérifier que l'eau sort du tube le plus au centre de la partie ronde de l'adaptateur. Suivre les recommandations d'entretien figurant au chapitre 9 de la notice.
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 21 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 |
| Cyprus | May 26, 2021 | Still on market |
| Czechia | May 26, 2021 | Still on market |
| Germany | May 26, 2021 | Still on market |
| EL | May 26, 2021 | Still on market |
| Spain | May 26, 2021 | Still on market |
| Croatia | May 26, 2021 | Still on market |
| Hungary | May 26, 2021 | 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 |
| Luxembourg | May 26, 2021 | Still on market |
| Netherlands | May 26, 2021 | Still on market |
| Poland | May 26, 2021 | Still on market |
| Portugal | May 26, 2021 | Still on market |
| Romania | May 26, 2021 | Still on market |
| Sweden | May 26, 2021 | 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.
03760243000089Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
376024300adaptateurTU200152UDI 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 - OTHERCertificate 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 →376024300adaptateurTUOn the marketRISKONTROL CAS INOX376024300adaptateurTUOn the marketRISKONTROL CEFLA INOX376024300adaptateurTUOn the marketRISKONTROL FA C 2376024300adaptateurTUOn the marketRISKONTROL FA E2376024300adaptateurTUOn the marketRISKONTROL FA S1376024300adaptateurTUOn the marketNo certificate specifically references this device's Basic UDI-DI.