Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• Caution

  Il est recommandé de désinfecter l'applicateur avant sa première utilisation. Ne pas immerger l’applicateur dans des solutions désinfectantes. Ne pas lubrifier l’applicateur. Nota : il est important d’enlever tout résidu de pâte et bien nettoyer l’applicateur après chaque utilisation pour éviter une éventuelle corrosion de celui-ci par la pâte (présence de chlorure d’aluminium). Vérifier la bonne fixation du porte-capsule avant utilisation ainsi que la bonne mise en place de l’ensemble capsule/canule dans l’applicateur. Respecter les conditions d’entretien présentées au chapitre 6 de la notice d’utilisation.

Primary placement in France; available across 30 countries total.

Trade name

Expasyl Applicator

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.

03760243000782

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.

376024300appliexpaSV

Reference / catalog number

260900

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

—

Additional information URL

https://www.acteongroup.com/documentation

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 03760243000782× 1 unitBase unit
  • 03760243007057× 1 unit

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

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

• Q010204RETRACTION WIRES AND GINGIVAL RETRACTORS

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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