Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  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.

Primary placement in France; available across 21 countries total.

Trade name

RISKONTROL SIRONA B

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

03760243000386

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

376024300adaptateurTU

Reference / catalog number

200154

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes. This device is intended for multiple use.

Additional information URL

https://www.acteongroup.com/documentation

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q0199ODONTOLOGY DEVICES - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.