Organization name

Allergan Industrie SAS

SRN

FR-MF-000000490

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Do not re-use
• Do not resterilize
• Check the expiry date on the product label. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do no use the syringe. Sterility of this device cannot be guaranteed if the device is re-used. For the needles : Used needles must be thrown away in the appropriate containers. Do the same for the syringes. Please consult the current applicable directives to ensure their correct elimination. Never try to straighten a bent needle; throw it away and replace it.

  OTHER

Primary placement in France; available across 31 countries total.

Trade name

Juvéderm VOLITE

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.

03701487900643

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.

B-03701487900643

Reference / catalog number

96659-UDI

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 III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Hyaluronic acid gel (12mg/mL) with 0.3% lidocaine hydrochloride. Indications: Treatment by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity by intra-dermal injection by an authorized medical practitioner in accordance with local applicable regulation.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU03

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

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

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