Organization name

ADODERM GMBH

SRN

DE-MF-000005720

Manufacturer status

Active

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

• Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)
• Biological risks
• Consult instructions for use
• Consult healthcare professional before use
• Contains a medicinal substance
• Do not re-use
• P103 – Read label before use.
• P333 – If skin irritation or rash occurs: P314 – Get medical advice/attention if you feel unwell.

Primary placement in Germany; available across 32 countries total.

Trade name

VARIOFILL®

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.

04260468960117

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-04260468960117

Reference / catalog number

VBC

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

VARIOFILL® for Gluteal Augmentation is a class III device with no medical purpose according to MDR Annex XVI. It is a dermal filler made of hyaluronic acid gel of non-animal origin indicated for volume restoration and contouring of the buttocks. The device (the gel) is presented in a 10 ml pre-filled syringe packed in a blister and a carton box and is to be used with rigid blunt cannula (16G or larger diameter). VARIOFILL® for Gluteal Augmentation is based on the development and of the gained experience of similar class III dermal fillers “VARIODERM” and VARIOFILL® Body Contour manufactured by ADODERM GmbH (CE mark between 2010 and 2015). VARIOFILL for Gluteal Augmentation is identical to former VARIOFILL® Body Contour (same specification, same manufacturing process). - Sodium Hyaluronate from non-animal origin - High final gel concentration for good volume creation and long lasting - high viscosity (high performance product: volume creation) - pH, osmolality biocompatible with implanted tissue - particle size 80 to 150 µm for good volume creation and good injectability - DVS cross linking agent - volume; 10 mL in plastic syringe: minimum quantity for visible volume creation. - sterile product - biocompatible product

Additional information URL

No additional information URL provided by the manufacturer.

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

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